At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...

FDA Commissioner Marty Makary announced a new pilot program that will provide bonus payments to drug reviewers who complete their evaluations ahead of schedule. This initiative aims to enhance the ...

The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines ...

The Food and Drug Administration announced on Thursday the first round of experimental drugs to be included in a priority voucher program. This FDA initiative is designed to expedite drug review ...

A new report estimates speeding up FDA drug approvals by one year could generate over $10 trillion in economic value from faster medical innovation.

The US Food and Drug Administration (FDA) has released a call for comments on a new transparency and drug review program contained within the Prescription Drug User Fee Act V (PDUFA V), which is ...

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Patients with no other options are watching an agency turn on its own scientists — and the trust that took a century to build ...

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight reduction under the FDA’s National Priority Voucher framework. STEP UP (n=1407) ...

Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...