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FDA publishes a draft guidance with recommendations to oncologic drug sponsors about measuring ovarian toxicity in relevant clinic...[ Price : $8.95]
The DC federal court agrees with FDA that a suit against the agency over identifying an attorney in a regulated company on a form ...[ Price : $8.95]
FDA accepts for review a Satsuma Pharmaceuticals NDA resubmission for STS101 (dihydroergotamine nasal powder) for the acute treatm...[ Price : $8.95]
Based on just-reported Phase 3 trial data, Axsome Therapeutics says it will submit an NDA for on AXS-12 (reboxetine) and its use i...[ Price : $8.95]
FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To S...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Limerick, Ireland-based Regeneron Ireland Designated Act...[ Price : $8.95]
President-elect Donald Trump names Johns Hopkins surgeon and public policy researcher Marty Makary as his nomination to be the nex...[ Price : $8.95]
FDA issues a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class 3...