FDA grants priority review for a Merck sNDA to extend the use of its Prevymis to CMV prophylaxis in kidney transplant patients.
FDA accepts an Iveric Bio NDA for avacincaptad pegol for priority review with a Breakthrough Therapy designation to treat geographic atrophy secondary...
Federal Register notice: FDA provides an opportunity to submit written comments on recommendations by the World Health Organization to impose internat...
Eisai CEO Ivan Cheung says he expects full FDA approval for the early Alzheimers drug Leqembi by this summer if the agency gives the drug priority rev...
FDA approves Chiesis Lamzede to treat some manifestations of alpha-mannosidosis in adults and children.
Federal Register notice: FDA withdraws a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the agency has scientific dat...
FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and ANDA applicants.
FDA commissioner Robert Califf announces a project to explore ways the agency can respond to and counter misleading health information in a variety of...