The sBLA is supported by results from the phase IIIDESTINY-Breast06 trial (NCT04494425), which showed that patients with HER2 ...

The FDA expects to issue a decision in the first quarter of 2025, and if the agency grants approval, it will expand the biomarker-eligible population for the drug.

Zymeworks is awaiting key regulatory decisions for zanidatamab, with potential EU and China approvals following. Read more ...

AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in ...

Mesoblast Limited has potential FDA approval of Remestemcel-L and promising late-stage therapies for chronic low back pain ...

Capricor Therapeutics Inc (NASDAQ:CAPR) shares are trading higher Tuesday after the company announced intent to file a ...

announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®.

Capricor Therapeutics shares rose in premarket trading Tuesday after the company said it plans to file a biologics license application for Deramiocel, its Duchenne muscular dystrophy cardiomyopathy ...

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old ...

announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft ®. “I am proud ...