GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep ...

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

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

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

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

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 ...

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 ...

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 ...

The Global Coalition for Adaptive Research (GCAR) has executed an agreement to evaluate AstraZeneca's AZD1390 compound in the ...

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 ...