Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application ...

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in ...

Capricor initiated its rolling submission process for the deramiocel BLA in October 2024, based on a successful pre-BLA meeting with the FDA. The completion of the submission process has also ...

Shares of Capricor Therapeutics CAPR gained 8.4% on Thursday following the completion of the submission of a biologics license application (BLA) to the FDA seeking full approval for deramiocel to ...