FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing adulterated and misbranded medical devices that have...
HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance at security checkpoi...
FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe and rare kidney disea...
Despite HHS secretary Robert F. Kennedy, Jr.s promises to boost transparency at HHS and its health agencies, staff cuts now occurring will likely crip...
FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and vaccine skeptic Robert...
Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-paclitaxel significantly ...
Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device.
FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Peter Marks departure ...