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FDA accepts for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatri...[ Price : $8.95]
FDA issues a guidance to give sponsors or applicants the recommended format and content for submission of physiologically based ph...[ Price : $8.95]
FDA announces a 12/7 public workshop on quantitation of AAV-based gene therapy products.[ Price : $8.95]
FDA says the Vyaire Medical recall of 2,150 units of its Tri-Flo suction system is Class 1.[ Price : $8.95]
HelloLife recalls four homeopathic drug products due to microbial contamination.[ Price : $8.95]
Federal Register notice: FDA releases a final guidance entitled Physiologically Based Pharmacokinetic Analyses Format and Content...[ Price : $8.95]
Janssen files an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults.[ Price : $8.95]
Federal Register notice: FDA announces the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee.