FDA approves a GlaxoSmithKline a supplemental NDA for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in patients ag...
FDA commissioner Stephen Hahn and associate commissioner Anand Shah say its time for investments and incentives to be added to FDAs efforts to bring m...
FDA clears a Minnetronix Medical 510(k) for the MindsEye Expandable Port for neurosurgical procedures.
Federal Register notice: FDA corrects a 7/24 notice on Annual Summary Reporting Requirements Under the Right to Try Act.
Federal Register notice: FDA makes available guidance documents related to Covid19 that have been implemented without prior comment.
A Pennsylvania federal court orders Boehringer Ingelheim to stop using several promotional claims for its COPD medications.
National Institute of Allergy and Infectious Diseases director Anthony Fauci dismisses any notion that a reported serious adverse reaction associated ...
FDA updates FAQs on submitting adverse events reports for medical devices marketed under emergency use authorizations.