If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for ...

Johnson & Johnson JNJ announced that the FDA has issued a complete response letter (“CRL”) to its biologics license ...

Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational ...

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), ...

Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 - On December ...

Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application to the U.S. FDA to add an additional ...

Merck & Co Inc (NYSE:MRK) revealed that it would discontinue the clinical development programs for vibostolimab and ...

Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment ...

Merck (MRK) announced the FDA has accepted the Biologics License Application for clesrovimab, or MK-1654, the company's ...

The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.

COPENHAGEN, Denmark, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental ...