FDA gives 510(k) clearance to LifeSignals Groups LifeSignals ECH remote monitoring patch platform to detect common cardiac arrhythmias.
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.
FDA issues Incyte a complete response letter on its BLA for retifanlimab, an intravenous PD-1 inhibitor for treating certain adult patients with local...
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...