News Releases

Research & Development

R&D
May.22.2019
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 BRAFV600E-mutant Metastatic Colorectal Cancer (36.1KB)
R&D
May.14.2019
Opdivo® (Nivolumab) Intravenous Infusion Received Additional Approvals related to Three Indications in Taiwan (104KB)
R&D
May.13.2019
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 (37.1KB)
R&D
Apr.03.2019
Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients (53.7KB)
R&D
Mar.28.2019
ONO Submits Supplemental Application of Opdivo® (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 (48.2KB)
R&D
Mar.27.2019
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 (115KB)
R&D
Mar.26.2019
A Short-Acting Selective β1 Blocker, ONOACT® for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Ventricular Arrhythmia in Japan (108KB)
R&D
Mar.19.2019
ONO Submits Supplemental Application of Kyprolis® for Intravenous Injection, a Proteasome Inhibitor, for Additional Dosage and Administration for the Treatment of Relapsed or Refractory Multiple Myeloma in Japan (40.2KB)
R&D
Mar.14.2019
ONO and Novartis Pharma Receive a Supplemental Approval for Formulation with New Ingredient of Rivastach® Patch and Exelon® Patch for the Treatment of Alzheimer's Disease Dementia (40.5KB)
R&D
Mar.11.2019
BMSKK and ONO Submit Supplemental Applications of Orencia® for I.V. Infusion, Orencia® Syringe for S.C. Injection and Orencia® Autoinjector for S.C. Injection, a Selective T-cell Co-Stimulation Modulator, for Inhibition of Structural Damage of Joints in Rheumatoid Arthritis (55.7KB)
R&D
Feb.27.2019
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 (43.6KB)
R&D
Feb.19.2019
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 (96.1KB)
R&D
Feb.15.2019
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 (51.8KB)
R&D
Feb.15.2019
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer (48.2KB)
R&D
Jan.18.2019
Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy in Taiwan (71.4KB)
R&D
Jan.15.2019
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 (47.8KB)
R&D
Jan.15.2019
Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer (36.2KB)
R&D
Jan.10.2019
Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma (35.3KB)
R&D
Jan.09.2019
Opdivo® (Nivolumab) Demonstrates a Significant Extension in Overall Survival Versus Chemotherapy in Patients with Unresectable Advanced or Recurrent Esophageal Cancer in Phase III Clinical Study (42.4KB)
R&D
Jan.08.2019
ONO Receives Manufacturing and Marketing Approval in Japan for Demser® Capsule, a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma (64.7KB)
R&D
Jan.08.2019
ONO Receives a Manufacturing and Marketing Approval for BRAFTOVI® Capsule, a BRAF Inhibitor and MEKTOVI® Tablet, a MEK Inhibitor for Indication of Unresectable BRAF-Mutant Melanoma in Japan (58.3KB)
R&D
Dec.27.2018
ONO Submits an Application for Manufacturing and Marketing Approval in Japan for Ivabradine Hydrochloride (ONO-1162) for the Treatment of Chronic Heart Failure (116KB)
R&D
Nov.27.2018
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 (36.3KB)
R&D
Nov.27.2018
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 (48.4KB)
R&D
Nov.16.2018
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 (48.3KB)
R&D
Nov.02.2018
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 (71.7KB)
R&D
Oct.23.2018
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 (47.6KB)
R&D
Oct.23.2018
Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Durable Four-Year Survival Benefits in Patients with Advanced Melanoma (48.1KB)
R&D
Oct.23.2018
Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Durable Clinical Benefit in Previously Untreated Patients with MSI-H or dMMR Metastatic Colorectal Cancer (48.4KB)
R&D
Oct.22.2018
Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Shows Promising Results in Patients with Advanced Form of Bladder Cancer (47.1KB)
R&D
Oct.22.2018
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 (89.9KB)
R&D
Oct.15.2018
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 (48.0KB)
R&D
Oct.10.2018
U.S. Food and Drug Administration Accepts Karyopharm's New Drug Application for Selinexor and Grants Priority Review (35.1KB)
R&D
Oct.09.2018
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 (94.6KB)
R&D
Oct.03.2018
FDA Approves KYPROLIS® (Carfilzomib) Once-Weekly 70 mg/u in Combination with Dexamethasone (Kd70) for Patients with Relapsed or Refractory Multiple Myeloma (37.1KB)
R&D
Sep.25.2018
European Commission Approves BRAFTOVI® (encorafenib) in Combination with MEKTOVI® (binimetinib) for Advanced BRAF-mutant Melanoma (35.5KB)
R&D
Sep.19.2018
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 (68.2KB)
R&D
Aug.31.2018
Amgen Submits Supplemental New Drug Application for KYPROLIS® (carfilzomib) Once-Weekly 70 mg/u in Combination with Dexamethasone (36.8KB)
R&D
Aug.21.2018
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 (79.4KB)
R&D
Aug.20.2018
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 (47.9KB)
R&D
Aug.08.2018
Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVITM in Combination with MEKTOVI® and Cetuximab for BRAFV600E-mutant Metastatic Colorectal Cancer (35.1KB)
R&D
Aug.07.2018
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 (34.8KB)
R&D
Aug.02.2018
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 (48.1KB)
R&D
Jul.30.2018
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 (121KB)
R&D
Jul.30.2018
BRAFTOVI™ (encorafenib) + MEKTOVI® (binimetinib) Receives Positive CHMP Opinion for Advanced BRAF-mutant Melanoma (35.3KB)
R&D
Jul.19.2018
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 (33.3KB)
R&D
Jul.12.2018
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 (47.6KB)
R&D
Jul.02.2018
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 (48.4KB)
R&D
Jun.29.2018
Announcement of an Approval for OPALMON TABLET5μg, an Oral Prostaglandin E1 Analogue, in Thailand (35.8KB)
R&D
Jun.28.2018
Array Biopharma Announces FDA Approval of Braftovi™ (Encorafenib) in Combination with Mektovi® (Binimetinib) (50.8KB)
R&D
Jun.25.2018
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 (35.5KB)
R&D
Jun.22.2018
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 (102KB)
R&D
Jun.18.2018
China National Drug Administration Approves Country's First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC) (47.4KB)
R&D
Jun.05.2018
Opdivo Plus Chemotherapy Showed Improved Progression-Free Survival Versus Chemotherapy in First-Line Lung Cancer Patients with PD-L1 <1%, in CheckMate -227 Study to Be Presented at ASCO 2018 (106KB)
R&D
Jun.05.2018
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 (47.9KB)
R&D
Jun.05.2018
Array BioPharma Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with BRAF-mutant Advanced Melanoma (35.3KB)
R&D
Jun.04.2018
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 (48.7KB)
R&D
May.30.2018
Announcement on Establishment of Immune-mediated Inflammatory Diseases Consortium for Drug Development (34.7KB)
R&D
May.25.2018
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 (74.1KB)
R&D
May.07.2018
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) (69.9KB)
R&D
May.07.2018
Karyopharm Announces Positive Top-Line Data from Phase 2b STORM Study Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma (67.6KB)
R&D
Apr.26.2018
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 (56.9KB)
R&D
Apr.25.2018
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 (68.3KB)
R&D
Apr.19.2018
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 (44.3KB)
R&D
Apr.18.2018
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 (46.5KB)
R&D
Apr.17.2018
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) (71.6KB)
R&D
Apr.17.2018
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) (44.9KB)
R&D
Apr.16.2018
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) (38.9KB)
R&D
Apr.12.2018
Karyopharm's Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma (23.1KB)
R&D
Mar.28.2018
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 (45.3KB)
R&D
Mar.26.2018
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 (44.1KB)
R&D
Mar.19.2018
Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Hepatocellular Carcinoma Previously Treated with Sorafenib (66.8KB)
R&D
Feb.23.2018
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 (168KB)
R&D
Feb.07.2018
Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial (31.9KB)
R&D
Feb.06.2018
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) (89.4KB)
R&D
Jan.25.2018
Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer (44.8KB)
R&D
Jan.23.2018
Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Advanced or Recurrent Gastric Cancer or Gastro-esophageal Junction Cancer (66.4KB)
R&D
Jan.22.2018
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 (31.7KB)
R&D
Jan.15.2018
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 (48.4KB)
R&D
Dec.22.2017
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 (72.4KB)
R&D
Dec.22.2017
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 (73.7KB)
R&D
Dec.22.2017
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 (49.6KB)
R&D
Dec.21.2017
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 (44.7KB)
R&D
Dec.18.2017
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 (62.3KB)
R&D
Dec.06.2017
CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival (44.6KB)
R&D
Nov.29.2017
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 (43.9KB)
R&D
Nov.16.2017
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 (68.3KB)
R&D
Nov.10.2017
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 (76.3KB)
R&D
Nov.08.2017
Opdivo (nivolumab) Demonstrates Superior Three-Year Survival Benefit for Patients with Previously Treated Advanced Renal Cell Carcinoma (RCC) (44.1KB)
R&D
Nov.07.2017
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 (65.0KB)
R&D
Oct.31.2017
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 (44.4KB)
R&D
Oct.30.2017
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 (66.9KB)
R&D
Oct.25.2017
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 (34.9KB)
R&D
Oct.17.2017
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 (44.3KB)
R&D
Oct.17.2017
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 (44.3KB)
R&D
Sep.29.2017
ONO and BMSKK Submit Supplemental Application for Opdivo® (Nivolumab) and Yervoy® (Ipilimumab) Combination Therapy for Unresctable Melanoma in Japan (51.7KB)
R&D
Sep.28.2017
Ono and Seikagaku Announce Initiation of a Late-Stage Phase II Clinical Trial of SI-613 for Treatment of Enthesopathy (98.6KB)
R&D
Sep.27.2017
Bristol-Myers Squibb's Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib (45.0KB)
R&D
Sep.22.2017
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 (83.1KB)
R&D
Sep.20.2017
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 (65.2KB)
R&D
Sep.19.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Unresectable or Metastatic Melanoma in South Korea (40.7KB)
R&D
Sep.14.2017
Array BioPharma Announces FDA Acceptance for Review of Binimetinib and Encorafenib New Drug Applications for Patients with Advanced BRAF-mutant Melanoma (31.3KB)
R&D
Sep.13.2017
Phase 3 BEACON CRC Safety Lead-In Results in BRAF-Mutant Colorectal Cancer Presented at European Society for Medical Oncology Congress (31.1KB)
R&D
Sep.13.2017
Phase 3 COLUMBUS Part 2 Results in BRAF-Mutant Melanoma Presented at European Society for Medical Oncology Congress (30.9KB)
R&D
Sep.12.2017
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 (45.6KB)
R&D
Sep.11.2017
Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer (64.6KB)
R&D
Sep.11.2017
Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Study (43.6KB)
R&D
Sep.08.2017
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 (44.3KB)
R&D
Sep.01.2017
Long-Term Analysis of Phase 3 Head-To-Head Study Confirms KYPROLIS® (Carfilzomib) Regimen Extends Overall Survival in Patients with Relapsed Multiple Myeloma (35.4KB)
R&D
Aug.30.2017
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 (66.6KB)
R&D
Aug.16.2017
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 (74.5KB)
R&D
Aug.16.2017
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 (45.4KB)
R&D
Aug.03.2017
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 (46.1KB)
R&D
Jul.13.2017
Second Phase III Study Shows Kyprolis® (Carfilzomib) Regimen Significantly Improves Overall Survival in Patients with Relapsed Multiple Myeloma (35.3KB)
R&D
Jul.06.2017
Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint (43.8KB)
R&D
Jul.06.2017
Array BioPharma Submits New Drug Applications to FDA for Binimetinib and Encorafenib in Advanced Melanoma (30.8KB)
R&D
Jun.19.2017
Extended Follow-Up Data Evaluating Opdivo (nivolumab) Shows Durable Response in Adult Patients with Relapsed or Progressed Classical Hodgkin Lymphoma (137KB)
R&D
Jun.05.2017
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 (186KB)
R&D
Jun.05.2017
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 (168KB)
R&D
Jun.05.2017
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 (182KB)
R&D
Jun.05.2017
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 (175KB)
R&D
Jun.05.2017
Opdivo (nivolumab) Data in Patients with Advanced Cervical, Vaginal and Vulvar Cancers from Phase 1/2 CheckMate -358 Presented at ASCO (181KB)
R&D
May.25.2017
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma (154KB)
R&D
May.18.2017
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 (66.3KB)
R&D
May.08.2017
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 (192KB)
R&D
Apr.28.2017
OPDIVO® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Advanced Renal Cell Carcinoma Who Have Received Prior Anti-angiogenic Therapy in Taiwan (49.8KB)
R&D
Apr.24.2017
Opdivo® (nivolumab) Designated for the Treatment of Biliary Tract Cancer Under the SAKIGAKE Designation System (42.8KB)
R&D
Apr.24.2017
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 (149KB)
R&D
Apr.06.2017
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 (151KB)
R&D
Apr.05.2017
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 (152KB)
R&D
Apr.05.2017
Bristol-Myers Squibb Announces Results from CheckMate -143, a Phase 3 Study of Opdivo (nivolumab) in Patients with Glioblastoma Multiforme (125KB)
R&D
Apr.05.2017
Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma (160KB)
R&D
Mar.30.2017
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 (80.9KB)
R&D
Mar.28.2017
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 (132KB)
R&D
Mar.24.2017
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 (63.8KB)
R&D
Mar.02.2017
Phase III Head-to-Head Trial Showed KYPROLIS® (Carfilzomib) Significantly Improved Overall Survival Compared to Velcade® (Bortezomib) in Relapsed or Refractory Multiple Myeloma Patients (33.8KB)
R&D
Feb.08.2017
U.S. Food and Drug Administration Approves Parsabiv™ (Etelcalcetide) to Treat Secondary Hyperparathyroidism in Adult Patients on Hemodialysis (32.6KB)
R&D
Feb.03.2017
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer (182KB)
R&D
Jan.20.2017
Bristol-Myers Squibb Provides Regulatory Update in First-line Lung Cancer (137KB)
R&D
Jan.20.2017
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) (77.6KB)