FDA publishes two 510(k) guidances on ultrasound and related types of devices.
Intarcia Therapeutics accepts an FDA proposal to allow an advisory committee to review and address a 2021 CDER decision not to approve the companys Ty...
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...
