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 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).

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

GSK (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.

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 ...

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

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

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, highlighting notable ocular toxicities and missed opportunities for dosing ...

David Mulligan, PhD, previews the FDA's ODAC meeting discussing the application of belantamab mafodotin-based combinations for the treatment of multiple myeloma.