2021.

• Jan.25.2021 R & D

  U.S. Food and Drug Administration Approves OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma

• Jan.22.2021 R & D

  ONO Receives a Manufacturing and Marketing Approval of Adlumiz® (Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer Cachexia in Japan

• Jan.21.2021 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer

• Jan.21.2021 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma

• Jan.07.2021 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) as Adjuvant Treatment for Resected Esophageal or Gastroesophageal Junction Cancer Following Chemoradiotherapy

• Jan.07.2021 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Combined with Chemotherapy as First-Line reatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma

2020.

• Dec.25.2020 R & D

  Bristol Myers Squibb Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme(115 KB)

• Dec.17.2020 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for First-Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer in South Korea(238 KB)

• Dec.10.2020 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Treatment of Unresectable Advanced or Recurrent Gastric Cancer in Japan(144 KB)

• Nov.30.2020 R & D

  Forxiga approved in Japan for the treatment of chronic heart failure(316 KB)

• Nov.27.2020 R & D

  Combination Therapy concerning Opdivo and Yervoy Approved in Japan for First–Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer(204 KB)

• Nov.27.2020 R & D

  ONO Receives Approval of BRAFTOVI® Capsule, a BRAF Inhibitor and MEKTOVI® Tablet, a MEK Inhibitor for Additional Indication of Unresectable, Advanced or Recurrent BRAF-Mutant Colorectal Cancer in Japan(194 KB)

• Nov.27.2020 R & D

  New Treatment Regimen Available for KYPROLIS® for Intravenous Injection, a Proteasome Inhibitor, in Combination with Darzalex® plus Dexamethasone for Treatment of Relapsed or Refractory Multiple Myeloma in Japan(136 KB)

• Nov.26.2020 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(111 KB)

• Nov.09.2020 R & D

  FOIPAN® Tablets, a Protease Enzyme Inhibitor, Started Clinical Study in Patients with Novel Coronavirus Infection (COVID-19)(99 KB)

• Nov.09.2020 R & D

  Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer(114 KB)

• Oct.27.2020 R & D

  Ono and Takeda Submit Supplemental Application for Opdivo® (Nivolumab) and CABOMETYX® (Cabozantinib) Combination Therapy in Japan to Expand the Use for Treatment of Unresectable or Metastatic Renal Cell Carcinoma(127 KB)

• Oct.27.2020 R & D

  ONO and BMSKK Submit Supplemental Applications for Opdivo and Yervoy in Combination Treatment to Expand the Use for First-line Treatment of Unresectable Advanced or Recurrent Malignant Pleural Mesothelioma in Japan(189 KB)

• Oct.20.2020 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma(116 KB)

• Oct.19.2020 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(113 KB)

• Oct.08.2020 R & D

  Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial(115 KB)

• Oct.05.2020 R & D

  Bristol Myers Squibb Announces Update on CheckMate -915 Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo in Resected High-Risk Melanoma Patients(138 KB)

• Oct.05.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma(114 KB)

• Sep.25.2020 R & D

  Opdivo (nivolumab) Significantly Improves Disease Free-Survival vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial(135 KB)

• Sep.25.2020 R & D

  Opdivo and Yervoy Combination Therapy Approved in Japan to Expand Use for the Treatment of Microsatellite Instability High (MSI-High) Colorectal Cancer, and Opdivo for Additional Dosage and Administration in Monotherapy Dosing Regimen(219 KB)

• Sep.23.2020 R & D

  Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial(136 KB)

• Sep.23.2020 R & D

  Opdivo (nivolumab) Demonstrated Superior Disease-Free Survival in Patients with Resected Esophageal or Gastroesophageal Junction Cancer Compared to Placebo in the Adjuvant Setting(386 KB)

• Sep.23.2020 R & D

  Opdivo (nivolumab) Plus Chemotherapy Demonstrated Significant Overall and Progression-Free Survival Benefits Versus Chemotherapy in First-Line Treatment of Gastric and Esophageal Cancers(143 KB)

• Sep.23.2020 R & D

  Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer(114 KB)

• Sep.22.2020 R & D

  Phase III Study Result Evaluating Opdivo in Combination with Bevacizumab and Chemotherapy in Chemotherapy-naïve Patients with Stage IIIB/IV or Recurrent Non-squamous Non-small Cell Lung Cancer Unsuitable for Radical Radiation Presented at ESMO 2020(190 KB)

• Sep.22.2020 R & D

  Phase II / III (ATTRACTION-4) Study Result Evaluating Opdivo in Combination with Chemotherapy in Patients with Unresectable Advanced or Recurrent Gastric Cancer Who are Previously Untreated with the First-line Therapy Presented at ESMO 2020(140 KB)

• Sep.18.2020 R & D

  Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(117 KB)

• Sep.16.2020 R & D

  European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma(115 KB)

• Aug.24.2020 R & D

  FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen with DARZALEX® (daratumumab) and Dexamethasone in Both Once- and Twice-Weekly Dosing Regimens(136 KB)

• Aug.21.2020 R & D

  ONO Receives a Supplemental Approval in Japan for Velexbru® Tablet 80mg, a BTK Inhibitor, for Additional Indication of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma(166 KB)

• Aug.12.2020 R & D

  CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers(143 KB)

• Aug.12.2020 R & D

  CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival(160 KB)

• Aug.11.2020 R & D

  Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma(115 KB)

• Aug.03.2020 R & D

  Opdivo in Combination with Bevacizumab and Chemotherapy Demonstrates a Significant Improvement of Progression-Free Survival in Chemotherapy-naïve Patients with Stage IIIB/IV or Recurrent Non-squamous Non-small Cell Lung Cancer Unsuitable for Radical Radiation in Phase III Clinical Study(188 KB)

• Jul.30.2020 R & D

  Development of Therapeutic Drugs for Novel Coronavirus Infection (COVID-19)(102 KB)

• Jun.29.2020 R & D

  ONO Recieves Manufacturing and Marketing Approval in Japan for Parsabiv® Intravenous Injection Syringe for Dialysis, a Calcimimetic Agent(129 KB)

• Jun.29.2020 R & D

  A Short-Acting Selective β₁ Blocker, Onoact® for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Tachyarrhythmia Associated with Sepsis in Japan(186 KB)

• Jun.29.2020 R & D

  Ono Receives a Manufacturing and Marketing Approval in Japan of "Ongentys® Tablets 25mg", a Peripheral COMT Inhibitor for the Improvement of Parkinson's Disease Patients with Motor Fluctuations(151 KB)

• Jun.11.2020 R & D

  Ono and Seikagaku Announce the Results from a Phase III Clinical Study in Japan of ONO-5704/SI-613 in Patients with Knee Osteoarthritis Presented at an Academic Conference(148 KB)

• Jun.11.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy(115 KB)

• Jun.05.2020 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Additional Indication of Unresectable Advanced or Recurrent Squamous Cell Carcinoma of Esophageal Cancer in Taiwan(187 KB)

• Jun.05.2020 R & D

  FOIPAN® Tablets, a Protease Enzyme Inhibitor, ONO Has Started Clinical Studies for Novel Coronavirus Infection (COVID-19)(100 KB)

• May.27.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer(130 KB)

• May.18.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%(153 KB)

• May.14.2020 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Treatment of Previously Untreated Unresectable Advanced or Recurrent Gastric Cancer in Japan(115 KB)

• May.14.2020 R & D

  Three-Year Data from CheckMate -227 Confirm Durable, Long-Term Survival Benefit for Opdivo (nivolumab) Plus Yervoy (ipilimumab) vs. Chemotherapy in Metastatic First-Line Non-Small Cell Lung Cancer Patients with PD-L1 ≥1%(149 KB)

• May.14.2020 R & D

  Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Limited Chemotherapy Significantly Improves Overall Survival vs. Chemotherapy Alone for Patients with First-Line Metastatic Non-Small Cell Lung Cancer in CheckMate -9LA Study(113 KB)

• Apr.21.2020 R & D

  Bristol Myers Squibb Announces Positive Topline Result from Pivotal Phase 3 Trial Evaluating Opdivo® (nivolumab) plus Yervoy® (ipilimumab) vs. Chemotherapy in Previously Untreated Malignant Pleural Mesothelioma(113 KB)

• Apr.21.2020 R & D

  Ono and Takeda Announce Results from Phase 3 CheckMate -9ER Study for Opdivo® (Nivolumab) and CABOMETYX® (Cabozantinib) Combination Therapy in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(183 KB)

• Apr.13.2020 R & D

  U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-mutant Metastatic Colorectal Cancer (CRC) after Prior Therapy(140 KB)

• Apr.13.2020 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Additional Indication of Unresectable Advanced or Recurrent Squamous Cell Carcinoma of Esophageal cancer in South Korea(139 KB)

• Apr.09.2020 R & D

  Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer(113 KB)

• Mar.26.2020 R & D

  ONO and BMSKK Submit Supplemental Application for Opdivo plus Yervoy in Combination Treatment with Chemotherapy in Japan to Expand the Use for First-Line Treatment of Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer(201 KB)

• Mar.25.2020 R & D

  ONO Receives a Manufacturing and Marketing Approval for Velexbru® Tablet 80mg, a BTK inhibitor, for Treatment of Recurrent or Refractory Primary Central Nervous System Lymphoma in Japan(129 KB)

• Mar.12.2020 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib(115 KB)

• Mar.04.2020 R & D

  ONO Submits Supplemental Application of BRAFTOVI® Capsule, a BRAF Inhibitor and MEKTOVI® Tablet, a MEK Inhibitor for Additional Indication of Unresectable, Advanced or Recurrent BRAF-Mutant Colorectal Cancer in Japan(112 KB)

• Feb.27.2020 R & D

  ONO Submits Supplemental Application for Approval for Opdivo® (Nivolumab) to Expand the Use for Treatment of Unresectable Advanced or Recurrent Non-small Cell Lung Cancer, in Combination Treatment with Chemotherapy in Japan(196 KB)

• Feb.21.2020 R & D

  BMSKK and ONO Receive Approval of Orencia® for I.V. Infusion, Orencia® Syringe for S.C. Injection and Orencia® Auto-injector for S.C. Injection, a Selective T-cell Co-Stimulation Modulator in Japan, to Include the Description of Prevention of Structural Damage of Joints in Current Indication of Rheumatoid Arthritis(148 KB)

• Feb.21.2020 R & D

  ONO Receives Approval of Opdivo® (Nivolumab) for Additional Indications of Unresectable Advanced or Recurrent Esophageal Cancer, and MSI-High Unresectable Advanced or Recurrent Colorectal Cancer in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(174 KB)

• Feb.17.2020 R & D

  Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 42-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(115 KB)

• Feb.17.2020 R & D

  Updated CheckMate -025 Results Show 26% of Patients Treated with Opdivo are Alive at Five Years in Patients with Previously Treated Advanced or Metastatic Renal Cell Carcinoma(113 KB)

• Feb.03.2020 R & D

  Bristol-Myers Squibb Withdraws European Application of Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer(136 KB)

• Jan.24.2020 R & D

  ONO Announces Result from Phase III Clinical Study Evaluating Opdivo® (Nivolumab) in Patients with Platinum-Refractory Advanced or Recurrent Ovarian Cancer(111 KB)

• Jan.16.2020 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer(113 KB)

• Jan.06.2020 R & D

  Ono and Seikagaku Submit a New Drug Application for Manufacturing and Marketing Approval for ONO-5704/SI-613 for the Treatment of Osteoarthritis in Japan(202 KB)

2019.

• Dec.25.2019 R & D

  ONO and BMSKK Submit Supplemental Application for Approval of Opdivo and Yervoy Combination Therapy to Expand the Use for First-Line Treatment of Unresectable, Advanced or Recurrent Non-Small Cell Lung Cancer in Japan(188 KB)

• Dec.24.2019 R & D

  Karyopharm Submits New Drug Application to U.S. FDA for XPOVIO® (selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma(150 KB)

• Dec.19.2019 R & D

  U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (Braftovi Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy(149 KB)

• Dec.09.2019 R & D

  Two Clinical Results for Tirabrutinib (ONO-4059), a BTK Inhibitor, in Patients with “Primary Central Nervous System Lymphoma”, and “Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma” Presented at ASH 2019(150 KB)

• Nov.27.2019 R & D

  ONO Submits Supplemental Application for Additional Opdivo® Intravenous Infusion Monotherapy Dosage and Schedule in Japan(101 KB)

• Nov.27.2019 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval in Japan for Tirabrutinib Hydrochloride (ONO-4059), a BTK Inhibitor, for the Treatment of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma(123 KB)

• Nov.22.2019 R & D

  ONO Receives Supplemental Approval of KYPROLIS® for Intravenous Injection, a Proteasome Inhibitor, in Japan for Additional Dosage and Administration for a Kd Once-weekly Regimen in Relapsed or Refractory Multiple Myeloma(129 KB)

• Nov.21.2019 R & D

  Bristol-Myers Squibb Announces Update on CheckMate -915 for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo Alone in Patients with Resected High-Risk Melanoma and PD-L1 <1%(116 KB)

• Nov.12.2019 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma(120 KB)

• Nov.12.2019 R & D

  ONO and BMSKK Submit Supplemental Application for Approval of Additional Indication of Opdivo and Yervoy Combination Therapy in Japan for the Treatment of MSI-H Colorectal Cancer(186 KB)

• Oct.23.2019 R & D

  CheckMate -9LA, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Combined with Chemotherapy, Meets Primary Endpoint Demonstrating Superior Overall Survival Compared to Chemotherapy Alone in First-Line Lung Cancer(40 KB)

• Oct.01.2019 R & D

  Opdivo (Nivolumab) Demonstrates Statistically Significant Overall Survival Benefit versus Chemotherapy in Patients with Esophageal Cancer in Phase III ATTRACTION-3 Study Presented at ESMO 2019(52 KB)

• Sep.30.2019 R & D

  Five-Year Outcomes for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrate Durable Long-Term Survival Benefits in Patients with Advanced Melanoma(36 KB)

• Sep.30.2019 R & D

  Adjuvant Treatment with Opdivo (nivolumab) Continues to Demonstrate Extended Recurrence-Free Survival at Three Years in Resected High-Risk Melanoma Patients(36 KB)

• Sep.30.2019 R & D

  Bristol-Myers Squibb Announces Final Results from CheckMate -227 Part 1 Demonstrating Superior Overall Survival for Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) vs. Chemotherapy in Advanced Non-Small Cell Lung Cancer(65 KB)

• Sep.20.2019 R & D

  ONO Receives a Manufacturing and Marketing Approval for Coralan® Tablet for the Treatment of Chronic Heart Failure in Japan(120 KB)

• Sep.17.2019 R & D

  Amgen Announces Phase 3 CANDOR Study Combining Kyprolis® (Carfilzomib) and Darzalex® (Daratumumab) Meets Primary Endpoint of Progression-Free Survival(36 KB)

• Sep.11.2019 R & D

  Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients(36 KB)

• Sep.06.2019 R & D

  Bristol-Myers Squibb Provides Update on Phase 3 Opdivo (nivolumab) CheckMate -548 Trial in Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme(36 KB)

• Aug.28.2019 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval for Tirabrutinib Hydrochloride (ONO-4059), a BTK inhibitor, for Treatment of Recurrent or Refractory Primary Central Nervous System Lymphoma in Japan(37 KB)

• Aug.08.2019 R & D

  ONO Submits an Application of ONOACT® for Intravenous Infusion 50mg・150mg, a Short-Acting Selective β1 Blocker for Additional Indication of Tachyarrhythmia Associated with Sepsis for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(119 KB)

• Jul.25.2019 R & D

  Bristol-Myers Squibb Provides Update on Part 2 of CheckMate -227(37 KB)

• Jul.25.2019 R & D

  Bristol-Myers Squibb Announces CheckMate -227 Part 1a Meets Co-Primary Endpoint of Overall Survival(51 KB)

• Jul.08.2019 R & D

  Array BioPharma Announces Interim Analysis Results from the BEACON CRC Trial of BRAFTOVI + MEKTOVI + Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer at the ESMO 21st World Congress on Gastrointestinal Cancer(36 KB)

• Jul.05.2019 R & D

  Karyopharm Announces FDA Approval of XPOVIO^TM (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma(35 KB)

• Jun.25.2019 R & D

  Bristol-Myers Squibb Announces Results from CheckMate -459 Study Evaluating Opdivo (nivolumab) as a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma(36 KB)

• Jun.05.2019 R & D

  Five-Year Survival Observed in Longest Follow-up to Date of Advanced Melanoma Patients Treated with the Combination of Opdivo (nivolumab) and Yervoy (ipilimumab)(36 KB)

• Jun.05.2019 R & D

  Bristol-Myers Squibb Announces First Presentation of Results for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination in Advanced Hepatocellular Carcinoma at ASCO 2019(36 KB)

• May.30.2019 R & D

  ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Indication of Unresectable Advanced or Recurrent Esophageal Cancer in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(48 KB)

• May.22.2019 R & D

  Array BioPharma Announces BRAFTOVI + MEKTOVI + Cetuximab Meet Primary Endpoints of ORR and OS in Phase 3 BEACON CRC Trial Interim Analysis for the Treatment of BRAF^V600E-mutant Metastatic Colorectal Cancer(35 KB)

• May.14.2019 R & D

  [email protected] (Nivolumab) Intravenous Infusion Received Additional Approvals related to Three Indications in Taiwan(102 KB)

• May.13.2019 R & D

  Bristol-Myers Squibb Announces Phase 3 CheckMate -498 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo (nivolumab) Plus Radiation in Patients with Newly Diagnosed MGMT-Unmethylated Glioblastoma Multiforme(36 KB)

• May.10.2019 R & D

  Certain Media Coverage relating to Opdivo Reported on May 9(47 KB)

• Apr.03.2019 R & D

  Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients(53 KB)

• Mar.28.2019 R & D

  ONO Submits Supplemental Application of [email protected] (Nivolumab) for Indication of MSI-H Unresectable Advanced or Recurrent Colorectal Cancer That Has Progressed Following Chemotherapy, for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(47 KB)

• Mar.27.2019 R & D

  A selective sodium-glucose co-transporter 2 (SGLT2) inhibitor Forxiga receives additional regulatory approval on indication and dosage and administration in type-1 diabetes in Japan(109 KB)

• Mar.26.2019 R & D

  A Short-Acting Selective β1 Blocker, [email protected] for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Ventricular Arrhythmia in Japan(106 KB)

• Mar.19.2019 R & D

  ONO Submits Supplemental Application of [email protected] for Intravenous Injection, a Proteasome Inhibitor, for Additional Dosage and Administration for the Treatment of Relapsed or Refractory Multiple Myeloma in Japan(39 KB)

• Mar.14.2019 R & D

  ONO and Novartis Pharma Receive a Supplemental Approval for Formulation with New Ingredient of [email protected] Patch and [email protected] Patch for the Treatment of Alzheimer's Disease Dementia(40 KB)

• Mar.11.2019 R & D

  BMSKK and ONO Submit Supplemental Applications of [email protected] for I.V. Infusion, [email protected] Syringe for S.C. Injection and [email protected] Autoinjector for S.C. Injection, a Selective T-cell Co-Stimulation Modulator, for Inhibition of Structural Damage of Joints in Rheumatoid Arthritis(54 KB)

• Feb.27.2019 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval of Opicapone (ONO-2370) for the Treatment of Parkinson's Disease Patients with Motor Fluctuations in Japan(42 KB)

• Feb.19.2019 R & D

  Ono and Seikagaku Announce the Topline Results from a Phase III Confirmatory Study of ONO-5704/SI-613 in Patients with Knee Osteoarthritis in Japan(94 KB)

• Feb.15.2019 R & D

  Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer(47 KB)

• Feb.15.2019 R & D

  Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(51 KB)

• Jan.18.2019 R & D

  [email protected] (Nivolumab) Intravenous Infusion Approved for Expanded Use in Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy in Taiwan(70 KB)

• Jan.15.2019 R & D

  Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination [email protected], [email protected] and [email protected] in BRAF-Mutant Metastatic Colorectal Cancer(35 KB)

• Jan.15.2019 R & D

  European Commission Approves Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) for First-Line Treatment of Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma(47 KB)

• Jan.10.2019 R & D

  Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma(35 KB)

• Jan.09.2019 R & D

  [email protected] (Nivolumab) Demonstrates a Significant Extension in Overall Survival Versus Chemotherapy in Patients with Unresectable Advanced or Recurrent Esophageal Cancer in Phase III Clinical Study(41 KB)

• Jan.08.2019 R & D

  ONO Receives a Manufacturing and Marketing Approval for [email protected] Capsule, a BRAF Inhibitor and [email protected] Tablet, a MEK Inhibitor for Indication of Unresectable BRAF-Mutant Melanoma in Japan(57 KB)

• Jan.08.2019 R & D

  ONO Receives Manufacturing and Marketing Approval in Japan for [email protected] Capsule, a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma(60 KB)

2018.

• Dec.27.2018 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval in Japan for Ivabradine Hydrochloride (ONO-1162) for the Treatment of Chronic Heart Failure(113 KB)

• Nov.27.2018 R & D

  Bristol-Myers Squibb Announces CheckMate -451 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo Plus Yervoy Vs. Placebo as A Maintenance Therapy in Patients with Extensive-Stage Small Cell Lung Cancer After Completion of First-Line Chemotherapy(47 KB)

• Nov.27.2018 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval of Anamorelin (ONO-7643), a Ghrelin Receptor Agonist, for the Treatment of Cancer Cachexia in Japan(36 KB)

• Nov.16.2018 R & D

  Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma(47 KB)

• Nov.02.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Intermediate and Poor Risk Previously Untreated Advanced Renal Cell Carcinoma in Combination Therapy with Ipilimumab in Taiwan(70 KB)

• Oct.23.2018 R & D

  Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Durable Clinical Benefit in Previously Untreated Patients with MSI-H or dMMR Metastatic Colorectal Cancer(47 KB)

• Oct.23.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Durable Four-Year Survival Benefits in Patients with Advanced Melanoma(47 KB)

• Oct.23.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(47 KB)

• Oct.22.2018 R & D

  Bristol-Myers Squibb Provides Update on the Ongoing Regulatory Review of Opdivo Plus Low-Dose Yervoy in First-Line Lung Cancer Patients with Tumor Mutational Burden ®10 mut/Mb(88 KB)

• Oct.22.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Shows Promising Results in Patients with Advanced Form of Bladder Cancer(46 KB)

• Oct.15.2018 R & D

  Bristol-Myers Squibb Announces Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer(47 KB)

• Oct.10.2018 R & D

  U.S. Food and Drug Administration Accepts Karyopharm's New Drug Application for Selinexor and Grants Priority Review(34 KB)

• Oct.09.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Indication of Previously Untreated Intermediate and Poor Risk Advanced Renal Cell Carcinoma in Combination with Ipilimumab, and Change in Administration Method for Intravenous Infusion Duration in South Korea(92 KB)

• Oct.03.2018 R & D

  FDA Approves KYPROLIS® (Carfilzomib) Once-Weekly 70 mg/㎡ in Combination with Dexamethasone (Kd70) for Patients with Relapsed or Refractory Multiple Myeloma(36 KB)

• Sep.25.2018 R & D

  European Commission Approves BRAFTOVI® (encorafenib) in Combination with MEKTOVI® (binimetinib) for Advanced BRAF-mutant Melanoma(35 KB)

• Sep.19.2018 R & D

  ONO and Novartis Submit a Supplemental Application for Formulation with New Ingredient of Rivastach® Patch and Exelon® Patch for Treatment of Alzheimer's Disease Dementia(67 KB)

• Aug.31.2018 R & D

  Amgen Submits Supplemental New Drug Application for KYPROLIS® (carfilzomib) Once-Weekly 70 mg/㎡ in Combination with Dexamethasone(36 KB)

• Aug.21.2018 R & D

  Opdivo Approved for Supplemental Applications for Expanded Indications of Malignant Pleural Mesothelioma and Adjuvant Treatment of Melanoma, Change in Dosage and Administration (D&A) of Single Dosing Regimen, and Expanded indication of Renal Cell Carcinoma in Opdivo and Yervoy Combination Therapy(78 KB)

• Aug.20.2018 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer(47 KB)

• Aug.08.2018 R & D

  Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVITM in Combination with MEKTOVI® and Cetuximab for BRAF^V600E-mutant Metastatic Colorectal Cancer(285 KB)

• Aug.07.2018 R & D

  Karyopharm Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma(34 KB)

• Aug.02.2018 R & D

  European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection(47 KB)

• Jul.30.2018 R & D

  BRAFTOVI™ (encorafenib) + MEKTOVI® (binimetinib) Receives Positive CHMP Opinion for Advanced BRAF-mutant Melanoma(34 KB)

• Jul.30.2018 R & D

  ONO Submits Supplemental Application of ONOACT® for Intravenous Infusion 50mg・150mg, Short-Acting Selective β₁ Blocker for Indication of Ventricular Arrhythmia for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(118 KB)

• Jul.19.2018 R & D

  Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma(33 KB)

• Jul.12.2018 R & D

  Opdivo + Low-Dose Yervoy is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and Irinotecan(47 KB)

• Jul.02.2018 R & D

  Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting(47 KB)

• Jun.29.2018 R & D

  Announcement of an Approval for OPALMON TABLET5μg, an Oral Prostaglandin E₁ Analogue, in Thailand(35 KB)

• Jun.28.2018 R & D

  Array Biopharma Announces FDA Approval of Braftovi® (Encorafenib) in Combination with Mektovi® (Binimetinib)(50 KB)

• Jun.25.2018 R & D

  Array BioPharma Announces a 62% Observed Overall Survival at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO 20th World Congress on Gastrointestinal Cancer(35 KB)

• Jun.22.2018 R & D

  U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ®10 mut/Mb(99 KB)

• Jun.18.2018 R & D

  China National Drug Administration Approves Country's First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC)(46 KB)

• Jun.15.2018 R & D

  Opdivo Plus Chemotherapy Showed Improved Progression-Free Survival Versus Chemotherapy in First-Line Lung Cancer Patients with PD-L1 &lt;1%, in CheckMate -227 Study to Be Presented at ASCO 2018(103 KB)

• Jun.05.2018 R & D

  Array BioPharma Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with BRAF-mutant Advanced Melanoma(35 KB)

• Jun.05.2018 R & D

  Opdivo (nivolumab) 3 mg/kg Demonstrates Sustained, Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) 10 mg/kg for Broad Range of Patients with Resected Stage III or IV Melanoma(47 KB)

• Jun.04.2018 R & D

  Opdivo (nivolumab) Plus Low-Dose (1mg/kg) Yervoy (ipilimumab) Provided Significant and Sustained Health-Related Quality of Life Improvements in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma in CheckMate -214 Study(48 KB)

• May.30.2018 R & D

  Announcement on Establishment of Immune-mediated Inflammatory Diseases Consortium for Drug Development(34 KB)

• May.25.2018 R & D

  ONO and BMSKK Receive Approval for Opdivo® and Yervoy® Combination Therapy for Treatment of Unresectable Melanoma as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(72 KB)

• May.07.2018 R & D

  Karyopharm Announces Positive Top-Line Data from Phase 2b STORM Study Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma(66 KB)

• May.07.2018 R & D

  European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer (NSCLC)(68 KB)

• Apr.26.2018 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval for Metyrosine (ONO-5371), a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma in Japan(56 KB)

• Apr.25.2018 R & D

  ONO Submits Applications for Manufacturing and Marketing Approval for Encorafenib, a BRAF Inhibitor and Binimetinib, a MEK Inhibitor for Indication of Unresectable BRAF-mutant Melanoma in Japan(67 KB)

• Apr.19.2018 R & D

  U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Patients with Small Cell Lung Cancer and Grants Priority Review(43 KB)

• Apr.18.2018 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma(45 KB)

• Apr.17.2018 R & D

  In CheckMate -141, Opdivo (nivolumab) Demonstrated Sustained Overall Survival (OS) Advantage over Standard of Care in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)(45 KB)

• Apr.17.2018 R & D

  Opdivo Plus Low-Dose Yervoy Combination Reduces the Risk of Progression or Death by 42% Versus Chemotherapy in First-Line Lung Cancer Patients with High Tumor Mutational Burden (TMB)(70 KB)

• Apr.16.2018 R & D

  Opdivo (nivolumab), First PD-1 Inhibitor to Demonstrate Superior Survival Benefit Compared with Chemotherapy in a Predominantly Chinese Population with Previously Treated Non-Small Cell Lung Cancer (NSCLC)(38 KB)

• Apr.12.2018 R & D

  Karyopharm's Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma(23 KB)

• Mar.28.2018 R & D

  U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for Previously Treated Patients with MSI-H or dMMR Metastatic Colorectal Cancer for Priority Review(44 KB)

• Mar.26.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Advanced or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma and for Expanded Use in Recurrent or Advanced Classical Hodgkin Lymphoma in South Korea(43 KB)

• Mar.19.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Hepatocellular Carcinoma Previously Treated with Sorafenib(65 KB)

• Feb.23.2018 R & D

  Orencia® for Intravenous Infusion 250 mg, Selective T-cell Co-stimulation Modulator: Approval for Additional Indication of Active Polyarticular Juvenile Idiopathic Arthritis for Partial Change in Approved items of Manufacturing and Marketing Approval in Japan(164 KB)

• Feb.07.2018 R & D

  Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial(31 KB)

• Feb.06.2018 R & D

  Pivotal Phase 3 CheckMate -227 Study Demonstrates Superior Progression-Free Survival (PFS) with the Opdivo Plus Yervoy Combination Versus Chemotherapy in First-Line Non-Small Cell Lung Cancer (NSCLC) Patients with High Tumor Mutation Burden (TMB)(87 KB)

• Jan.25.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer(44 KB)

• Jan.23.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Advanced or Recurrent Gastric Cancer or Gastro-esophageal Junction Cancer(65 KB)

• Jan.22.2018 R & D

  Combination of Encorafenib, Binimetinib and Cetuximab Demonstrated an 8 Month Median Progression-Free Survival in BRAF-Mutant Colorectal Cancer in Updated Safety Lead-In Results from BEACON Phase 3 Trial(31 KB)

• Jan.15.2018 R & D

  ONO and BMSKK Submit Supplemental Application for Opdivo and Yervoy Combination Therapy for Unresctable or Metastatic Renal Cell Carcinoma in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(47 KB)

2017.

• Dec.22.2017 R & D

  ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Dosage and Administration of Single Dosing Regimen in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(49 KB)

• Dec.22.2017 R & D

  ONO Submit Supplemental Application of Opdivo® (Nivolumab) for Expanded Use of the Adjuvant Treatment of Melanoma in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(72 KB)

• Dec.22.2017 R & D

  ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Indication of Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(71 KB)

• Dec.21.2017 R & D

  Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease(44 KB)

• Dec.18.2017 R & D

  U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review(61 KB)

• Dec.06.2017 R & D

  CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival(44 KB)

• Nov.29.2017 R & D

  European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor- Risk Patients with Advanced Renal Cell Carcinoma(43 KB)

• Nov.16.2017 R & D

  Encouraging Response Observed with Opdivo (nivolumab) Plus Investigational IDO1 Inhibitor, BMS-986205, in Heavily Pre-Treated Patients with Advanced Cancers in Phase 1/2a Study CA017-003(67 KB)

• Nov.10.2017 R & D

  Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(75 KB)

• Nov.08.2017 R & D

  Opdivo (nivolumab) Demonstrates Superior Three-Year Survival Benefit for Patients with Previously Treated Advanced Renal Cell Carcinoma (RCC)(43 KB)

• Nov.07.2017 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Expanded Use in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated with Platinum-based Therapy(64 KB)

• Oct.31.2017 R & D

  European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) for Treatment of Patients with Resected High-Risk Advanced Melanoma(43 KB)

• Oct.30.2017 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Additional Indications of Relapsed or Progressed Classical Hodgkin Lymphoma, Locally Advanced Unresectable or Metastatic Urothelial Carcinoma, and Unresectable or Metastatic Melanoma(65 KB)

• Oct.25.2017 R & D

  Phase 3 A.R.R.O.W. Study of Once-Weekly Kyprolis® (Carfilzomib) Regimen Meets Primary Endpoint of Progression-Free Survival in Relapsed and Refractory Multiple Myeloma Patients(34 KB)

• Oct.17.2017 R & D

  U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review(43 KB)

• Oct.17.2017 R & D

  Opdivo Alone or Combined with Yervoy Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer Patients with High Tumor Mutation Burden, in Exploratory Analysis from Phase 1/2 Study CheckMate -032(43 KB)

• Sep.29.2017 R & D

  ONO and BMSKK Submit Supplemental Application for Opdivo® (Nivolumab) and Yervoy® (Ipilimumab) Combination Therapy for Unresctable Melanoma in Japan(51 KB)

• Sep.28.2017 R & D

  Ono and Seikagaku Announce Initiation of a Late-Stage Phase II Clinical Trial of SI-613 for Treatment of Enthesopathy(96 KB)

• Sep.27.2017 R & D

  Bristol-Myers Squibb's Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib(44 KB)

• Sep.22.2017 R & D

  ONO Receives Approval for OPDIVO® (Nivolumab) Intravenous Infusion for Treatment of Unresectable Advanced or Recurrent Gastric Cancer which Has Progressed after Chemotherapy as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(81 KB)

• Sep.20.2017 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Advanced Non-squamous Non-small Cell Lung Cancer which Has Been Previously Treated with Platinum-based Therapy in Taiwan(64 KB)

• Sep.19.2017 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Unresectable or Metastatic Melanoma in South Korea(40 KB)

• Sep.14.2017 R & D

  Array BioPharma Announces FDA Acceptance for Review of Binimetinib and Encorafenib New Drug Applications for Patients with Advanced BRAF-mutant Melanoma(31 KB)

• Sep.13.2017 R & D

  Phase 3 COLUMBUS Part 2 Results in BRAF-Mutant Melanoma Presented at European Society for Medical Oncology Congress(30 KB)

• Sep.13.2017 R & D

  Phase 3 BEACON CRC Safety Lead-In Results in BRAF-Mutant Colorectal Cancer Presented at European Society for Medical Oncology Congress(30 KB)

• Sep.12.2017 R & D

  Opdivo Plus Yervoy Combination Demonstrated Superior Overall Survival and Showed Durable Responses in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma in Phase 3 CheckMate -214 Trial(44 KB)

• Sep.11.2017 R & D

  Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Study(44 KB)

• Sep.11.2017 R & D

  Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer(62 KB)

• Sep.08.2017 R & D

  CheckMate -214 Study Evaluating Opdivo in Combination with Yervoy Stopped Early for Demonstrating Overall Survival Benefit in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(43 KB)

• Sep.01.2017 R & D

  Long-Term Analysis of Phase 3 Head-To-Head Study Confirms KYPROLIS® (Carfilzomib) Regimen Extends Overall Survival in Patients with Relapsed Multiple Myeloma(35 KB)

• Aug.30.2017 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indications of Advanced Renal Cell Carcinoma, Relapsed or Progressed Classical Hodgkin Lymphoma, Recurrent or Metastatic Head and Neck, Locally Advanced or Metastatic Urothelial Carcinoma, and Unresectable or Metastatic Melanoma in Combination with Ipilimumab in South Korea(64 KB)

• Aug.16.2017 R & D

  Bristol-Myers Squibb Announces Topline Results from CheckMate -214, a Phase 3 Study of Opdivo in Combination with Yervoy in Intermediate and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(44 KB)

• Aug.16.2017 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck with Disease Progression on or after Platinum-based Therapy in Taiwan(73 KB)

• Aug.03.2017 R & D

  Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan(45 KB)

• Jul.13.2017 R & D

  Second Phase III Study Shows Kyprolis® (Carfilzomib) Regimen Significantly Improves Overall Survival in Patients with Relapsed Multiple Myeloma(35 KB)

• Jul.06.2017 R & D

  Array BioPharma Submits New Drug Applications to FDA for Binimetinib and Encorafenib in Advanced Melanoma(30 KB)

• Jul.06.2017 R & D

  Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint(43 KB)

• Jun.19.2017 R & D

  Extended Follow-Up Data Evaluating Opdivo (nivolumab) Shows Durable Response in Adult Patients with Relapsed or Progressed Classical Hodgkin Lymphoma(134 KB)

• Jun.05.2017 R & D

  Opdivo (nivolumab) Data in Patients with Advanced Cervical, Vaginal and Vulvar Cancers from Phase 1/2 CheckMate -358 Presented at ASCO(176 KB)

• Jun.05.2017 R & D

  Anti-LAG-3 (BMS-986016) in Combination with Opdivo (nivolumab) Showed Activity in Patients with Melanoma Who Were Relapsed or Refractory to Anti-PD-1/PD-L1 Therapy(171 KB)

• Jun.05.2017 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrated Promising Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer in Phase 2 CheckMate -142 Study(177 KB)

• Jun.05.2017 R & D

  First Presentation of Efficacy Data from CheckMate -204 Evaluating the Combination of Opdivo (nivolumab) and Yervoy (ipilimumab) Demonstrates Anti-tumor Activity in Advanced Melanoma Patients with Brain Metastases(164 KB)

• Jun.05.2017 R & D

  European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab) for Previously Treated Locally Advanced Unresectable or Metastatic Urothelial Carcinoma in Adults After Failure of Prior Platinum-Containing Therapy(181 KB)

• May.25.2017 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma(150 KB)

• May.18.2017 R & D

  ONO Receives Supplemental Manufacturing and Marketing Approval of KYPROLIS® for Intravenous Injection 10 mg and 40 mg, a Proteasome Inhibitor, in Relapsed or Refractory Multiple Myeloma(65 KB)

• May.08.2017 R & D

  European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy(188 KB)

• Apr.28.2017 R & D

  OPDIVO® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Advanced Renal Cell Carcinoma Who Have Received Prior Anti-angiogenic Therapy in Taiwan(48 KB)

• Apr.24.2017 R & D

  Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer(145 KB)

• Apr.24.2017 R & D

  Opdivo® (nivolumab) Designated for the Treatment of Biliary Tract Cancer Under the SAKIGAKE Designation System(41 KB)

• Apr.06.2017 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer(147 KB)

• Apr.05.2017 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma(156 KB)

• Apr.05.2017 R & D

  Bristol-Myers Squibb Announces Results from CheckMate -143, a Phase 3 Study of Opdivo (nivolumab) in Patients with Glioblastoma Multiforme(122 KB)

• Apr.05.2017 R & D

  Five-Year Survival Observed With Opdivo (nivolumab) in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC), in Phase 1 Study CA209-003(149 KB)

• Mar.30.2017 R & D

  Supplemental Application of Orencia® (Abatacept) Intravenous Injection 250 mg a Selective T-cell Co-stimulation Modulator for Treatment of Juvenile Idiopathic Arthritis for a Partial Change in Approved Items of Manufacturing and Marketing Approval(78 KB)

• Mar.28.2017 R & D

  Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) for the Treatment of Squamous Cell Cancer of the Head and Neck in Adults Progressing on or After Platinum-based Therapy(129 KB)

• Mar.24.2017 R & D

  ONO Receives Approval for OPDIVO® (Nivolumab) Intravenous Infusion for Treatment of Recurrent or Metastatic Head and Neck Cancer as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(62 KB)

• Mar.02.2017 R & D

  Phase III Head-to-Head Trial Showed KYPROLIS® (Carfilzomib) Significantly Improved Overall Survival Compared to Velcade® (Bortezomib) in Relapsed or Refractory Multiple Myeloma Patients(33 KB)

• Feb.08.2017 R & D

  U.S. Food and Drug Administration Approves Parsabiv® (Etelcalcetide) to Treat Secondary Hyperparathyroidism in Adult Patients on Hemodialysis(31 KB)

• Feb.03.2017 R & D

  Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer(178 KB)

• Jan.20.2017 R & D

  Data with OPDIVO® (nivolumab) Intravenous Infusion in Gastric Cancer from Phase III Clinical Study (ONO-4538-12) Presented at 2017 Gastrointestinal Cancer Symposium (ASCO GI 2017)(75 KB)

• Jan.20.2017 R & D

  Bristol-Myers Squibb Provides Regulatory Update in First-line Lung Cancer(134 KB)