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

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

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

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

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% Friday, halting the momentum the stock generated just a day earlier after ...

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

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

GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...

The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

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

The apex advisory body functioning under the Central Drugs Standard Control Organisation (CDSCO), Drugs Consultative ...

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and ...