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, ...
Green Matters on MSN

FDA Recalls 3 Tomato Sauces Over Botulism Risk — Check Your Pantry Now

First and Last Bakery, LLC, which is based in Hartford, Connecticut, issued the recall for three varieties of its tomato ...

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 ...
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 ...
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, ...

FDA Announces Recall on 3 Tomato Sauces for Potential Botulism Risk

The U.S. Food & Drug Administration (FDA) has announced a recall of three tomato sauces sold at Big Y and Stop & Shop stores ...

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.