FDA grants Amphix Bio a breakthrough device designation for its drug-device combination product for bone regeneration.
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment of adults with resect...
FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provells Euthyrox (levothyroxine sodium).
FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in the supine position.
Aldeyra Therapeutics resubmits an NDA for topical ocular reproxalap, an investigational new drug for treating signs and symptoms of dry eye disease.
Federal Register notice: FDA makes available a final guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical ...
Federal Register notice: FDA determines that U.S. Antibiotics Augmentin XR (amoxicillin; clavulanate potassium) extended-release tablet was not withdr...
FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer
