Exclusive: US FDA cleared pricey rare disease drug over reviewer objections

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...

FDA Staff in Meltdown as RFK Jr. Chaos Triggers Mass Exit Fears

A growing number of FDA employees are eyeing the exits as chaos and uncertainty sweep through the agency, according to ...

FDA recalls 580K bottles of this blood pressure medication: Is your medicine on the list?

The U.S. Food and Drug Administration recalled more than 580,000 bottles of a blood pressure medication. Is your medication ...
STAT

FDA digital advisers confront risks of therapy chatbots, weigh possible regulation

FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, ...
Fierce Biotech

FDA rejects Biohaven approval request for troriluzole, triggering R&D cost cutting

After a three-month delay, the FDA has now rejected an approval request based on the RWE. According to Biohaven, the FDA’s complete response letter “cited issues that can be inherent to real-world ...

UniQure shares plummet as FDA says inadequate clinical data for Huntington's therapy

UniQure said the U.S. Food and Drug Administration no longer agreed that clinical data for the Dutch company's gene therapy ...
STAT

Lawsuit against top FDA drug regulator is packed with incendiary texts, emails

A lawsuit filed against George Tidmarsh, who resigned from a top FDA post on Sunday, includes a series of incendiary texts ...

White House backs FDA head after ouster of top regulator

The administration, as well as HHS, publicly praised Marty Makary’s leadership despite persistent upheaval at the agency.