Eli Lilly’s star oral GLP-1 candidate orforglipron and Novo Nordisk’s Wegovy (semaglutide) were named voucher winners in a ...
The FDA announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to ...
For the first time, patients with abnormal cells detected in their bone marrow have a treatment option before the condition ...
The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, ...
FDA issues Class II recall for ADHD drug after quality concerns, with millions of prescriptions potentially impacted.
Botulinum toxin, commonly called Botox, is used to temporarily reduce wrinkles by paralyzing facial muscles. While it is ...
The FDA has sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable ...
The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...
Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...
The FDA approved Darzalex Faspro for the treatment of adults with high-risk smoldering multiple myeloma. The U.S. Food and ...
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 ...