FDA clears a Zebra Medical Vision 510(k) for the HealthPNX, an artificial intelligence alert for pneumothorax, based on chest x-rays.
Federal Register notice: FDA determines the regulatory review period for Auspex Pharmaceuticalss Austedo (deutetrabenazine), indicated for treating ch...
FDA approves Regeneron Pharmaceuticals Eylea (aflibercept) injection to treat all stages of diabetic retinopathy.
Connecticut attorney general William Tong leads a 44-state lawsuit against Teva Pharmaceuticals and 19 generic drug manufacturers that alleges a broad...
FDA approves Abiomeds expanded use of its Impella 5.0 and Impella LD heart pumps for treating cardiogenic shock.
FDA Review posts the product approval summaries for the week ending 5/10/2019.
FDA Review posts product approval summaries for the week ending 5/10/2019.
Federal Register notice: FDA makes available a guidance entitled Determining Whether to Submit an ANDA or a 505(b)(2) Application.