It was a busy week in the biotech sector with lots of regulatory and pipeline updates. Among bigwigs, Gilead Sciences, Inc.
Merck & Co Inc (NYSE:MRK) revealed that it would discontinue the clinical development programs for vibostolimab and ...
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), ...
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 ...
The FDA delays Johnson & Johnson's SC amivantamab approval for NSCLC over facility inspection issues, unrelated to product ...
The FDA issues a complete response letter to JNJ's BLA seeking approval for the subcutaneous formulation of Rybrevant in EGFR ...
Merck (MRK) announced the FDA has accepted the Biologics License Application for clesrovimab, or MK-1654, the company's ...
Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational ...
Johnson & Johnson (JNJ) injectable cancer drug Rybrevant developed with Halozyme (HALO) is declined by the FDA due to ...
Specifically, by week 1, patients treated with anx005 showed more than a 10-point improvement in muscle strength over ...
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 - On December ...