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Federal Register notice: FDA revises an information collection entitled Premarket Notification 21 CFR Part 807, Subpart E.[ Price : $8.95]
FDA publishes two 510(k) guidances on ultrasound and related types of devices.[ Price : $8.95]
Intarcia Therapeutics accepts an FDA proposal to allow an advisory committee to review and address a 2021 CDER decision not to app...[ Price : $8.95]
Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not meet the primary endpoint a statistically significant ris...[ Price : $8.95]
HHS publishes its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, including a fin...[ Price : $8.95]
Pfizer drops about half of the U.S. participants in its VALOR Lyme vaccine Phase 3 trial due to trial site good clinical practice ...[ Price : $8.95]
FDA grants priority review for a Merck sNDA to extend the use of its Prevymis to CMV prophylaxis in kidney transplant patients.[ Price : $8.95]
FDA accepts an Iveric Bio NDA for avacincaptad pegol for priority review with a Breakthrough Therapy designation to treat geograph...