Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not meet the primary endpoint a statistically significant risk reduction in those...
HHS publishes its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, including a final rule on DTC Rx dr...
Pfizer drops about half of the U.S. participants in its VALOR Lyme vaccine Phase 3 trial due to trial site good clinical practice violations.
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.
