FDA gives the green light to Phaxiam Therapeutics for a Phase 2 study (GLORIA) to evaluate its anti-Staphylococcus aureus phages in prosthetic joint i...
FDA approves a Journey Medical NDA for Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for treating rosacea inflammatory lesions.
FDA announces a pilot program designed to expedite the review of new therapies addressing unmet medical needs.
FDA removes the clinical holds on three CARsgen Therapeutics clinical trials evaluating CT053, CT041, and CT071.
FDA agrees on a Phase 3 study design for Disc Medicines bitopertin and its use in treating a rare sunlight sensitivity disorder.
FDA clears a Quanta Dialysis Technologies 510(k) for the use of its Quanta Dialysis System in the home setting.
A FDA advisory committee votes against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) for adults with Type 1 diabet...
FDA backpedals on safety warnings it required on CAR-T cell therapies related to secondary cancers, according to CBER director Peter Marks.
