Medical ethicist Arthur Caplan voices concerns about human subject protection in clinical trials due to significant staff cuts at FDA and HHS.
University of Chicago researchers explain how difficult it will be to improve government oversight over social media influencer promotions for FDA-reg...
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...
FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical trials.
FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...
FDA accepts for review an ITM Isotope Technologies NDA for 177Lu-edotreotide (ITM-11), a targeted radiopharmaceutical therapy for gastroenteropancreat...
Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a pivotal Phase 3 tri...
