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 ...
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 ...

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

(Reuters) -The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and ...
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 ...

FDA warns websites selling fake or unapproved forms of Botox, similar drugs

The FDA has sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable ...

Former Stanford professor accused of 'reprehensible' conduct quits top FDA job

Hilliard, the HHS spokesperson, told SFGATE on Tuesday that, “Secretary [Robert F.] Kennedy [Jr.] expects the highest ethical ...
STAT

FDA broadens search for new top drug regulator after early setbacks

George Tidmarsh left the agency amid accusations of misusing his authority and after clashing with another top official.

US FDA expands use of J&J's Caplyta as add-on depression drug

The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson's drug Caplyta as an add-on ...

The FDA Warns This Popular Skincare Treatment Comes with 'Potential Risk,' Including 'Disfigurement'

The FDA states that radiofrequency microneedling has a "potential risk," after receiving reports of complications such as ...
The American Journal of Managed Care

FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk MM

A new option is now approved to treat adults living with high-risk smoldering multiple myeloma (MM). 1 The FDA has greenlit ...

US FDA places clinical hold on Tenaya gene therapy trial for rare heart disease

Tenaya Therapeutics said on Friday the U.S. Food and Drug Administration has placed a clinical hold on its trial of an ...

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 ...