Bristol Myers Squibb says it will not initiate any new clinical trials globally before 4/13 due to coronavirus concerns.
Federal Register notice: FDA cancels a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation Preparation for ICCR-14 Meeting...
FDA says it will fund projects to help it better understand using real-world data to generate real-world evidence.
PhRMA says FDA should change a proposed survey on promotional implications of proprietary drug names if it intends to proceed with the survey.
FDA approves a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Genentechs Herc...
Federal Register notice: FDA announces its process for making available guidance documents related to the coronavirus public health emergency.
FDA accepts for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or excessive daytime slee...
FDA clears an Align Technology 510(k) for the iTero Element 5D Imaging System.