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 grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.
FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment with several targeted ...
The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change control plans.
