Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls).
FDA grows concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medical devices prior to...
Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump.
Federal Register notice: FDA announces its decision to exempt a list of Class 2 devices from premarket notification requirements.
FDA approves a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquired bacterial pneumoni...
FDA authorizes NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for patients with previ...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials Implementation of Section 505(o)(3) ...
Federal Register notice: FDA makes available its listing of Modifications to the List of Recognized Standards, Recognition List Number: 052.