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 ...

Shares of Capricor Therapeutics CAPR tanked 33% on Friday after it announced that the FDA issued a complete response letter ( ...

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 ...

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

Ultragenyx's UX111 gene therapy faces FDA delay due to facility issues; analysts adjust price targets amid uncertain ...

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 ...