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 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 head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, resigned on November 2, 2025, one ...
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 ...
The FDA approved Darzalex Faspro for the treatment of adults with high-risk smoldering multiple myeloma. The U.S. Food and ...
The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo ...
An alleged extortion attempt, a petty yearslong grudge, shocking social media posts, and ominous text messages make up the ...
FDA issues Class II recall for ADHD drug after quality concerns, with millions of prescriptions potentially impacted.