The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.

On Tuesday, the FDA accepted for review Capricor Therapeutics Inc’s (NASDAQ:CAPR) Biologics License Application for ...

Capricor Therapeutics (CAPR) announced the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking ...

Capricor Therapeutics' shares rose after its biologics license application for deramiocel to treat a form of muscular dystrophy was given priority review by the Food and Drug Administration. Shares ...

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License ...

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for deramiocel (CAP-1002) for the treatment ...

In addition to the Priority Review, deramiocel has received Orphan Drug Designation from the FDA and EMA, as well as RMAT and ATMP Designations in the U.S. and Europe, respectively. Furthermore, ...

US FDA accepts for review GSK’s BLA for depemokimab for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps: London, UK Tuesday, March 4, 2025, 09:0 ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for emapalumab-Izsg for use ...

Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer's Disease in Australia TOKY ...

The global hemophilia treatment market is on a strong growth trajectory, with projections indicating a rise from USD 12.1 billion in 2024 to a remarkable USD 18.7 billion by 2034. This growth, driven ...

Step up to the plate, Houston area seniors! The Astros Foundation and Daikin Comfort Technologies North America, Inc. (Daikin) have announced an inaugural scholarship program, Daikin's Most Valuable ...