Federal Register notice: FDA announces a 5/14 Oncologic Drugs Advisory Committee meeting to discuss two Daiichi Sankyo NDAs.
Federal Register notice: FDA announces a 5/7 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting.
Federal Register notice: FDA determines that Casper Pharmas Antivert (meclizine hydrochloride) chewable tablets were not withdrawn from sale for reaso...
FDA clears a Spry Health 510(k) to market the Loop System, a clinical-grade wearable that measures pulse oximetry, respiration rate and heart rate.
Bellerophon Therapeutics and FDA reach agreement on the regulatory approval pathway for INOpulse, a proprietary pulsatile nitric oxide delivery system...
FDA approves a ViiV Healthcare NDA for Dovato (dolutegravir and lamivudine), as a complete regimen for treating human immunodeficiency virus type 1 in...
FDA Review posts the Federal Register notices for the week ending 4/5/2019
Federal Register notice: FDA makes available a final guidance entitled Risk Evaluation and Mitigation Strategy: FDAs Application of Statutory Factors ...