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 FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR ...
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), ...
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 ...
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 - On December ...
Johnson & Johnson (JNJ) injectable cancer drug Rybrevant developed with Halozyme (HALO) is declined by the FDA due to ...
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 ...
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