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 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).

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

The goal with ProKidney's rilparencel-branded therapy is “to demonstrate the therapy’s potential to preserve kidney function in patients with advanced chronic kidney disease and diabetes.” ...

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

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

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

Sarepta Therapeutics said it will eliminate 36% of its workforce—approximately 500 jobs—in a restructuring that follows the ...

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

Mesoblast’s RYONCIL ® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal ...