FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug ...

FDA officials plan to present data they claim links the Covid vaccine to 25 deaths in children at a CDC vaccine panel meeting ...

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

An advisory committee will meet next week to review the information and make recommendations for the upcoming fall season.

Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval ...

The Washington Post was the first to report the plans, citing four people who say the presentation will focus on reports of ...

FDA officials are expected to claim a connection between the COVID vaccine and pediatric deaths when they brief a CDC vaccine ...

If you're not over 65 or have certain risk factors, it might be hard to get one but not necessarily impossible. Here's what ...

The agency plans to highlight possible links between the shots and accounts of deaths involving children and birth defects to ...

The FDA is moving to scale back its long-standing use of expert panels to review drug applications, KFF Health News reported Sept. 12. George Tidmarsh, MD, PhD, director of the FDA’s Center for Drug ...