FDA will meet with Petros over proposed labeling changes for the companys Stendra erectile dysfunction medicine.
FDA approves Sol-Gel Technologies acne medication Twyneo that uses a patented technology to stabilize one of the active ingredients.
FDA grants Evren Technologies a breakthrough device designation for its Phoenix earbud device and its use in treating post-traumatic stress disorder.
Federal Register notice: FDA announces a 9/2-3 Cellular, Tissue and Gene Therapies Advisory Committee meeting.
Federal Register notice: FDA rescinds a 1/15 notice that identified seven types of reserved Class 1 devices that HHS had determined no longer require ...
FDA issues Iterum Therapeutics a complete response letter on its NDA for sulopenem etzadroxil/probenecid, indicated for treating treat multi-drug resi...
Federal Register notice: FDA extends the comment period for a 6/15 notice on: Exemption from Premarket Notification: Powered Patient Transports.
Federal Register notice: FDA and the Clinical Trials Transformation Initiative request applications for patient advocates interested in participating ...