Georgia, North Carolina, Iowa and Colorado health officials report adverse reactions observed at vaccination sites after administering Johnson & Johns...
Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.
Federal Register notice: CBER makes available version 2.2 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports...
Retired FDA psychiatry products director Thomas Laughren joines BetterLife Pharma as a regulatory advisor.
Bristol Myers Squibb announces positive topline results from the CheckMate-648 Phase 3 Opdivo trial in some esophageal cancers.
FDA grants Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for certain adult patients with unresectable locally advanced or me...
FDA posts a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions Baltimore manufacturing fac...