FDA accepts for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion.
FDA grants Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian cancer and endometrial ...
Two Hyman, Phelps & McNamara attorneys and a medical device regulation expert analyze a recent FDA draft guidance on artificial intelligence/machine l...
FDA approves AstraZenecas Farxiga to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in ad...
Cue Health files a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use.
FDA removes a partial clinical hold against Salarius Pharmaceuticals and its Phase 1/2 clinical trial evaluating seclidemstat in patients with Ewing s...
FDA medical reviewers ask the FDA Pulmonary-Allergy Drug Advisory Committee to consider the adequacy of pharmacokinetic and pharmacodynamic data to su...
FDA removes a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactically reduces the lik...
