FDA releases its latest batch of Warning Letters that include Apollo Care and Cord for Life.
FDA releases the FDA-483 with 11 observations issued following an inspection at Indias Aurobindo Pharma.
FDA issues a safety alert about online marketers selling pre-owned test strips or test strips not authorized for sale in the U.S. to consumers.
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Register notice: FDA determines that Casper Pharmas Antivert (meclizine hydrochloride) chewable tablets were not withdrawn from sale for reaso...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...