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 ...

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

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

A Maryland jury has convicted both former CytoDyn CEO Nader Pourhassan, Ph.D., and ex-Amarex CEO Kazem Kazempour on several ...

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

Checkpoint said in July that the FDA accepted for review its resubmission of the Biologics License Application for the drug and set a Prescription Drug User Fee Act goal date of Dec. 28. Shares were ...

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 ...