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

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).

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

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.

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

Ultragenyx fell by 26.05 percent week-on-week as investor sentiment was largely dragged down by the Food and Drug ...

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

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

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

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

The FDA issued a complete response letter to Genentech indicating it cannot approve the company’s biologic license ...