Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state claims against an over...
FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, South Korea.
Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.
FDA accepts for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy for treating adults w...
FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided authorization to begin ...
Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.
FDA approves a Medtronic PMA for its BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier for use in Parkinsons patients.
FDA moves over the weekend to rehire up to 300 scientists and reviewers who were terminated last week as part of the Trump Administrations cost-cuttin...
