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Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials Implementation of Section 505(o)(3) ...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.
Federal Register notice: FDA makes available a draft guidance entitled Breast Implants Certain Labeling Recommendations to Improve Patient Communicat...
Harvard Medical School researchers say publicly supported research helped at least 25% of all drugs approved by FDA between 2008 and 2017 and could be...
FDA acting commissioner Ned Sharpless reviews agency steps in 2019 to combat the opioid crisis by implementing the SUPPORT Act.
FDA releases a second method for evaluating presence of NDMA in ranitidine drug products.