Zachary Brennan

The US Government Accountability Office published a new report detailing concerns with the staffing of the FDA's drug inspection program, and the fact that the …

Novo Nordisk said Thursday that it plans to eventually halt all of its human insulin pen production globally, confirming an Endpoints News

Sen. Bill Cassidy (R-LA) will take over the Senate Health, Education, Labor, and Pensions Committee when the GOP gets control of the chamber in the next Congress, offering a change ...

President-elect Donald Trump has picked Robert F. Kennedy Jr. to be his next HHS secretary, likely giving the government's most powerful healthcare post to a …

The FDA on Monday offered new draft guidance to help drugmakers understand the nuts and bolts of FDA processes for developing and submitting an application …

The FDA on Thursday will convene an advisory committee to discuss the safety and efficacy of AstraZeneca's Andexxa, which won accelerated approval in 2018 to …

FDA Commissioner Rob Califf led the first meeting of FDA's digital health advisory committee, focusing on generative AI regulation. The agency has received over 1,000 AI-enabled medical device submissions and 300 drug/biologic submissions. The committee addressed premarket evaluation, risk management, and postmarket monitoring.

The FDA on Wednesday updated the label for Sandoz's decades-old leukemia drug fludarabine phosphate, as part of a wider initiative to revamp the labels for …

Members of an FDA advisory committee were not asked to vote Thursday on AstraZeneca's anticoagulant reversal drug Andexxa, but they did raise several safety and …

The Senate Judiciary Committee narrowly advanced a bill Thursday that would change the way the Patent Trial and Appeal Board operates, limiting the ability of …