FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...
Medical ethicist Arthur Caplan voices concerns about human subject protection in clinical trials due to significant staff cuts at FDA and HHS.
A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharmas compounded 100 mg indomethacin suppository.
FDA approves Shanghai Henlius Biologics Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentechs Perjeta (pertuzumab), a HER2-tar...
University of Chicago researchers explain how difficult it will be to improve government oversight over social media influencer promotions for FDA-reg...
FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical trials.
FDA accepts for review an ITM Isotope Technologies NDA for 177Lu-edotreotide (ITM-11), a targeted radiopharmaceutical therapy for gastroenteropancreat...
FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized therapies for rare genet...
