FDA clears a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures.
FDA grants Audentes Therapeutics a regenerative medicine advanced therapy designation for AT132 and its use in treating X-linked myotubular myopathy.
FDA posts a guidance on Quality Attribute Considerations for Chewable Tablets that provides the agencys current thinking on the critical quality attri...
FDA posts a guidance on Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.
Federal Register notice: FDA extends the comment period for a previous notice about study designs intended to generate data to support substantial evi...
Federal Register notice: FDA submits to OMB an information collection extension for Samples and Protocols.
Federal Register notice: FDA announces a 9/27 Neurological Devices Panel meeting to review a Sequent Medical PMA for the Woven Endobridge Aneurysm Emb...
FDA approves a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line treatment of certain...