The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...

Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

Replimune shares collapsed on Tuesday after the U.S. Food and Drug Administration rejected the clinical-stage biotechnology company's proposed advanced melanoma treatment. Shares of the Woburn, Mass., ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...

Investing.com -- Replimune Group, Inc. (NASDAQ: REPL) stock plunged 77% after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) ...

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...