Browsing items tagged “FDA approval | EVERSANA”

FDA Approves BMS’ Opdivo for Advanced ESCC After Chemotherapy

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #bms #escc #esophagealcancer #fda #priorityreview PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), following prior fluoropyrimidine- and platinum-based chemotherapy Approval from the U.S. regulator is based on results from […]

FDA Sets September Review Date for Novartis’ Multiple Sclerosis Targeted B-Cell Therapy, Ofatumumab

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #actionadate #b-celltherapy #fda #multiplesclerosis #novartis #ofatumumab #sbla PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) issued a notice to Swiss-based Novartis explaining that the agency has extended its review of the supplemental Biologics License Application (sBLA) for ofatumumab, a targeted B-cell therapy for relapsing multiple sclerosis (MS) The FDA is now expected to make a decision […]

Deciphera’s Qinlock Approved for Fourth-Line GIST Treatment by FDA

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #deciphera #fda #projectorbis #qinlock #realtimeoncologyreview PRICENTRIC BRIEF: The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.) The New Drug Application (NDA) […]