Federal Register notice: FDA announces a voluntary Total Product Life Cycle Advisory Program pilot that was agreed to between FDA and industry as part...
FDA expands the emergency use authorization for the Moderna and Pfizer/BioNTech bivalent Covid vaccine booster shots to cover children age six and old...
Evofem Biosciences discontinues its EVO100 development program of a drug to prevent chlamydia and gonorrhea in women.
FDA releases the form FDA-483 with 17 observations from an inspection at the Houston, TX-based Empower Pharmacy outsourcing facility.
Harm Reduction Therapeutics submits the first module of a planned rolling NDA for RiVive (3 mg intranasal naloxone), indicated as an over-the-counter ...
Federal Register notice: FDA announces the user fee rates for fiscal year 2023 for medical devices.
Three Hyman, Phelps & McNamara attorneys say several recent drug approvals appear to signal a new FDA interest in using confirmatory evidence despite ...
Merck exercises an option to collaborate with Moderna on a personalized cancer vaccine currently being evaluated in a Phase 2 trial.
