FDA Approves Opdivo for First-Line Treatment of Urothelial Carcinoma
RESEARCH TRIANGLE PARK, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the...
Sensorion Provides an Update on NOTOXIS
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.
Accord Healthcare has restarted its production of the cancer drug cisplatin, which has been in short supply in the U.S.
Merck Receives Positive EU CHMP Opinion for KEYTRUDA for Biliary Tract Cancer
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
EMA Validates Application for Opdivo for First-Line Treatment of
Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy Followed by Opdivo Demonstrates Significant Survival Benefits for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in Phase 3 CheckMate -901 Trial
he ongoing shortage of carboplatin and cisplatin across healthcare systems in the United States calls the current reliance on overseas manufacturing of these vital therapies into question, according to Daniel P. Petrylak, MD, who added that shifting the production of platinum-based chemotherapies back to the United States may serve to prevent future shortages.