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

In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...

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).

The Biologics License Application for full licensure of the Moderna COVID-19 vaccine, mRNA-1273, for active immunization to prevent COVID-19 in individuals 18 years of age and older has been ...

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

RED BANK, N.J., April 8, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced ...

PDUFA Goal date is November 16, 2024 Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Jan. 22, 2024 (GLOBE ...