FDA accepts for review an Ocuphire Pharma NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for treating pharmacologically-induced mydriasis.
Federal Register notice: FDA seeks comments on an information collection revision entitled FDA Advisory Committees; Information Collection Activities....
Federal Register notice: FDA announces the withdrawal of a guidance entitled Temporary Policy on Repackaging or Combining Propofol Drug Products Durin...
A new JAMA research article finds that between 2018 and 2021, FDA approved 210 new drugs and 21 (10.0%) were approved based on pivotal studies with nu...
FDA Inspection findings at Indias Biocon Biologics lead to a complete response letter on its BLA for a biosimilar version of bevacizumab (Genentechs A...
An FDA inspection of Indias Laurus Labs results in a Form 483 with two undisclosed observations.
Johnson & Johnsons Ethicon unit agrees to a $10 million settlement with Kentucky over alleged deceptive marketing practices involving the companys pel...
FDA posts a draft guidance entitled Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.
