Fierce Biotech

FDA reveals 2nd round of 'national priority' voucher winners, including obesity giants Lilly and Novo

Eli Lilly’s star oral GLP-1 candidate orforglipron and Novo Nordisk’s Wegovy (semaglutide) were named voucher winners in a ...
Fierce Pharma

FDA approves J&J's Darzalex as 1st treatment for smoldering multiple myeloma

For the first time, patients with abnormal cells detected in their bone marrow have a treatment option before the condition ...
STAT

FDA announces next round of priority review vouchers

The FDA announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to ...

FDA Drug Chief’s ‘Revenge’ Emails Revealed in Explosive Lawsuit

The head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, resigned on November 2, 2025, one ...
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 ...

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’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct

Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...
CURE

FDA Approves Darzalex Faspro in High-Risk Smoldering Multiple Myeloma

The FDA approved Darzalex Faspro for the treatment of adults with high-risk smoldering multiple myeloma. The U.S. Food and ...

US FDA awards six more fast-track vouchers to speed drug reviews

The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo ...
KSHB 41 Kansas City

'It's gas station heroin': Kansas City seeks to regulate kratom products following FDA warning

You've probably seen the signs on shops and gas stations selling 7OH and kratom. It's currently an unregulated industry in ...

Nationwide ADHD Medication Recall Update as FDA Sets Risk Level

FDA issues Class II recall for ADHD drug after quality concerns, with millions of prescriptions potentially impacted.