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...
The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approach in OGD-related communications to applicants.
Alkermes announces that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime sleepiness in patien...
