Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on substantial evidence rat...
Federal Register notice: FDA issues a proposed administrative order to remove orally administered phenylephrine in OTC nasal decongestants.
FDA cites a lack of adequate training in FY 2023 Good Laboratory Practice inspection form FDA-483s.
FDA approves the J&J Varipulse pulsed field ablation platform to treat atrial fibrillation.
Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with Duchenne muscular d...
FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE.
Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.
FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectivity.
