The FDA received a biologics license application for accelerated approval of RP1 plus nivolumab for advanced, pretreated ...

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License ...

The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

Resubmission addresses questions raised in January 2024 Complete Response Letter F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in ...

StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug ...

The FDA has accepted for review the resubmitted sBLA for dupilumab for the treatment of chronic spontaneous urticaria.

GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review a Biologics License Application, BLA, for Blenrep in combinations with bortezomib plus dexamethasone and ...

New York-based Regeneron Pharmaceuticals, Inc. (REGN) discovers, develops, manufactures, and commercializes medicines for treating serious medical conditions. Valued at a market cap of $81.1 billion, ...

On November 21, 2024, Replimune Group, Inc. (NASDAQ: REPL) made significant strides in the advancement of its lead product candidate, RP1. The company announced the submission of a biologics license ...

Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...

Omeros ( OMER, Financials) announced progress toward resubmitting its biologics license application for narsoplimab, its ...

REGENECYTE™ is an allogeneic hematopoietic stem cell therapy derived from human umbilical cord blood. It is approved for unrelated donor hematopoietic progenitor cell transplantation procedures ...