Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Food Safety News

GAO report says FDA is still failing to meet requirements of 2011 law

A key element of the law is the establishment of a system to trace food, which is key to reducing the severity of foodborne ...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates to the BLA in ...
BioSpace

FDA Delays Decision for Lilly’s Obesity Pill Orforglipron, Other Priority Voucher Awardees: Report

Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite ...
GlobalData on MSN

FDA prevails over EMA in 2025 novel drug approvals

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

Forever chemicals in makeup have uncertain health effects, FDA report finds

The nation's top food and product regulator said there are "significant" gaps in scientists' understanding of how PFAS in ...
Becker's Hospital Review

FDA lacks capacity to manage device recalls: Report

Low staffing at the FDA has prevented the agency from adequately overseeing the more than 190,000 devices under its purview, according to a Dec. 12 report from ProPublica and the Pittsburgh ...

FDA finds repeat quality failures at Houston's Empower Pharmacy in latest inspection, records show

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.