FDA posts 20 potential signals of serious risks/new safety information from the fourth quarter of 2023.
Rep. David Schweikert introduces legislation to require HHS to approve a fast-track designation for treatments for addictive substances and give the t...
FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
Gritstone Bio reports mixed data from an ongoing Phase 2 portion of a Phase 2/3 study evaluating Granite, a personalized neoantigen cancer vaccine for...
Eli Lilly says any revision of an FDA guidance on weight management drugs should incorporate a modern scientific characterization of obesity as a chro...
A report by Spotlight on America suggests FDA is increasing scrutiny over CooperSurgical and its manufacturing facility in North Tonawanda, NY, where ...
FDA posts a guidance entitled FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Bio...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance on Oxymetazoline Hydrochloride.
