News Releases

2018

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)
Jul.13.2018 Support for the Torrential Rain Damage in Western Japan (37.0KB)
Jul.13.2018 ONO Announces the Number of Medical Institutes at Dementia-Related Information Website “Dementia Healthcare Connected with Smile and Heart” Reached 400 Institutes, Where Interview Articles from the Institutes Have Been Posted (34.1KB)
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)
Jul.09.2018 Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights) (135KB)
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)
Jun.29.2018 Announcement of an Approval for OPALMON TABLET5μg, an Oral Prostaglandin E1 Analogue, in Thailand (35.8KB)
Jun.28.2018 Array Biopharma Announces FDA Approval of Braftovi™ (Encorafenib) in Combination with Mektovi® (Binimetinib) (50.8KB)
Jun.28.2018 Support for Relief Efforts to Earthquake in Northern Part of Osaka (37.1KB)
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)
Jun.22.2018 Notice of Resolutions Passed at The 70th Ordinary General Shareholders' Meeting
Jun.22.2018 Notice Concerning Issuance of Stock Options (Stock Acquisition Rights) (258KB)
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)
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)
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)
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)
Jun.05.2018 Array BioPharma Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with BRAF-mutant Advanced Melanoma (35.3KB)
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)
May.30.2018 Announcement on Establishment of Immune-mediated Inflammatory Diseases Consortium for Drug Development (34.7KB)
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)
May.25.2018 Notice to Convene the 70th Ordinary General Shareholders' Meeting
May.10.2018 Announcement on Financial Results for FY2017
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)
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)
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)
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)
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)
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)
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)
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)
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)
Apr.12.2018 Karyopharm's Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma (23.1KB)
Apr.05.2018 Announcement on Candidates of Members of the Board of Directors and Corporate Officers (82.6KB)
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)
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)
Mar.19.2018 Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Hepatocellular Carcinoma Previously Treated with Sorafenib (66.8KB)
Mar.14.2018 Ono Enters into New Collaboration Agreement with Merus N.V. (106KB)
Mar.01.2018 Completion of a New Tokyo Building (212KB)
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)
Feb.13.2018 Support for Relief Efforts to Eastern Taiwan Earthquake (21.5KB)
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)
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)
Feb.02.2018 Announcement on Financial Results for FY2017 3Q
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)
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)
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)
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)