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...
GE HealthCare recalls its Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detecto...
UK-based researchers say their analysis of drug company financial records doesnt support company claims that high drug prices are needed to support re...
FDA commissioner Robert Califf outlines ways the agency is taking additional steps as part of its response to the nations opioid crisis.
