FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected by the coronavirus.
The Association for Accessible Medications steps up pressure on Congress to reject legislation to change FDAs 180-day marketing exclusivity awards for...
FDA approves an Esperion NDA for Nexlizet (bempedoic acid and ezetimibe) as an adjunct to diet and maximally tolerated statin therapy for treating cer...
FDA launches a new pilot program to simplify public awareness about guidance documents that seek to modernize drug clinical trials and accelerate drug...
FDA clears a Companion Medical 510(k) for its InPen bolus insulin calculator for fixed dosing and meal estimation.
FDA approves a Cerovene ANDA for the first generic copy of Vyera Pharmaceuticals Daraprim (pyrimethamine) tablets for treating toxoplasmosis.
FDA clears a Baxter International 510(k) for its Peri-Strips Dry with Veritas Collagen Matrix, a staple line reinforcement material for bariatric surg...