Capricor Therapeutics Inc. and its CEO overhyped regulatory approval odds for its cell therapy to treat a serious heart ...

Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene ...

In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...

Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...

The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel ...

The goal with ProKidney's rilparencel-branded therapy is “to demonstrate the therapy’s potential to preserve kidney function ...