UCB says its BLA for plaque psoriasis drug bimekizumab is facing another FDA review extension.
Federal Register notice: FDAs Office of Womens Health and Office of Clinical Pharmacology announces a 10/11 public workshop: Menopause: Potential Impa...
Medline Industries recalls its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility concerns.
Federal Register notice: CBER requests information from stakeholders about critical scientific challenges and opportunities to advance individualized ...
FDA warns Tempe, AZ-based PureChemPros it is illegally manufacturing and distributing unapproved and misbranded new drugs that violate CGMP regulation...
Federal Register notice: FDA releases its FDA Information Technology Strategy, which is open for comments until 10/30.
FDA grants InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive thera...
Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.
