Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant a...
The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over laboratory-developed t...
FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advanced or metastatic me...
Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Evaluation of Automati...
Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use as Covid-19 pre-expos...
FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.
FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary supplements.
FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.
