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

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) is one of the Best 52-Week Low Stocks to Buy According to Analysts. On July 14, ...

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

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

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

Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...

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

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

US FDA 200+CRLs to help pharma industry engage in a more transparent manner: Experts: Shardul Nautiyal, Mumbai Friday, July 18, 2025, 08:00 Hrs [IST] US FDA 200+Complete Response ...

Rocket Pharmaceuticals received a regenerative medicine advanced therapy designation from the Food and Drug Administration for its heart disease treatment.

Pierre Fabre leads global development of tab-cel, an innovative therapy for EBV+ PTLD, with ongoing trials and potential FDA ...

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