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

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

Johnson & Johnson (NYSE:JNJ) has announced that the U.S. FDA has declined to approve an injectable version of its cancer ...

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 ...

These results, along with the potential for a Biologics License Application (BLA) submission in the second half of 2025 and a possible launch in the second half of 2026, strengthen the drug’s profile.

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

The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...

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 ...