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

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

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

(Alliance News) - GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory ...

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

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 ...

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

Researchers observed responses in patients with synovial sarcoma or myxoid/round cell liposarcoma treated with lete-cel.

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 ...

( (PGEN) ) has released its Q3 earnings. Here is a breakdown of the information Precigen, Inc. presented to its investors.Don ...

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

The pharma is seeking full approval for its anticoagulation reversal drug Andexxa, which the FDA granted accelerated approval ...