The Pharma Letter14h
Merck & Co’s clesrovimab BLA accepted by FDA
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), ...
Managed Healthcare Executive15h
FDA Accepts Biologics License Application for Infant RSV Antibody
If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for ...
Monthly Prescribing Reference17h
Clesrovimab Under Review for RSV Prevention in Infants
The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim ...
FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer
The FDA delays Johnson & Johnson's SC amivantamab approval for NSCLC over facility inspection issues, unrelated to product ...
FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC
The FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR ...
Merck: FDA To Review BLA For Clesrovimab - Quick Facts
Merck (MRK) announced the FDA has accepted the Biologics License Application for clesrovimab, or MK-1654, the company's ...
Merck’s Biologics License Application for clesrovimab accepted by FDA
Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational ...
PipelineReview.com22h
LIB Therapeutics Submits a Biologic License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol
CINCINNATI, OH, USA I 16, 2024 I LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company announced the submission of a ...
Johnson & Johnson says injectable Rybrevant rejected by FDA
Johnson & Johnson (JNJ) injectable cancer drug Rybrevant developed with Halozyme (HALO) is declined by the FDA due to ...