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

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

The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim ...

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

The FDA delays Johnson & Johnson's SC amivantamab approval for NSCLC over facility inspection issues, unrelated to product ...

Johnson & Johnson (JNJ) injectable cancer drug Rybrevant developed with Halozyme (HALO) is declined by the FDA due to ...

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

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 ...

Viridian (VRDN) shares shot up 25% after the company reported positive results from a Phase 3 study of veligrotug in the ...

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

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