FDA approves CSL Behrings Hizentra (immune globulin subcutaneous [human] 20% liquid) as maintenance therapy for chronic inflammatory demyelinating pol...
Federal Register notice: FDA seeks comments on an information collection extension for MedWatch: The FDA Medical Products Reporting Program (OMB Contr...
Federal Register notice: FDA amends a 1/23 notice about a 3/22 Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee ...
Q BioMed files with FDA for a new manufacturing facility to make strontium chloride Sr89 injection USP, a non-opioid injectable radiopharmaceutical to...
Bayer recalls Alka-Seltzer Plus packages that were sold at Walmart, CVS, Walgreens, and certain other stores in the U.S. due to an ingredient mislabel...
FDA publishes quarterly metrics on its performance processing ANDAs.
FDA delays indefinitely a final rule that would determine a medical products intended use based on the totality of the evidence.
Federal Register notice: FDA seeks comments on a proposed collection of information Health Care Professional Survey of Professional Prescription Drug...