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 ...

The FDA will convene experts on Nov. 6 to discuss challenges around regulating mental health products that use artificial ...

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 ...

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

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

The US FDA has issued new guidance on ways to expand development of non-opioid treatment options for chronic pain.

The U.S. Food and Drug Administration will hold an advisory panel meeting in November to examine the fast-emerging class of ...