Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational ...
Following a complete response letter and biologics license application resubmission, the FDA has approved remestemcel-L for ...
If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for ...
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company announced the submission of a Biologics ...
The FDA accepts MRK's BLA for clesrovimab, its monoclonal antibody, to protect infants from RSV disease. A decision from the ...
The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim ...
The FDA issued a complete response letter for the BLA submission of subcutaneous amivantamab for EGFR-mutated NSCLC, citing ...
Merck (MRK) announced the FDA has accepted the Biologics License Application for clesrovimab, or MK-1654, the company's ...
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 ...
Johnson & Johnson (JNJ) injectable cancer drug Rybrevant developed with Halozyme (HALO) is declined by the FDA due to ...