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.

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

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 ...

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 BLA approval is supported by data from the COBLT study, FDA dockets and public information, and from a RegeneCyte observational database.

GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...

Shares of Replimune Group topped recent 52-week highs in the after-hours market, following news the company received breakthrough therapy designation for its RP1 and submitted a biologics license ...

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 ...