Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...

The FDA has accepted the resubmission of a BLA for odronextamab for the treatment of patients with relapsed/refractory ...

for clesrovimab and set a Prescription Drug User Fee Act (PDUFA) date of 10 June 2025. Data supporting the BLA comes from two trials for which results were presented during the IDWeek meeting in ...

Regenxbio Inc (RGNX) showcases robust financial positioning and strategic progress in gene therapy, despite challenges in ...

Capricor Therapeutics (CAPR) announced the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking ...

Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...

Three Democratic senators want answers from Health and Human Services Secretary Robert F. Kennedy Jr. about his private meetings with drugmakers alongside President Trump at his Mar-a-Lago club in ...

President Donald Trump’s nominee to lead the Food and Drug Administration was grilled ... reschedule a federal vaccine advisory committee meeting that was intended to help select the makeup ...

A Prescription Drug User Fee Act target date of December 16, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the Biologics License ...

FDA grants Priority Review to Capricor's deramiocel for Duchenne cardiomyopathy, setting an August 2025 decision date with no ...

The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.