"We can do better," commissioner says ...

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...

A new daily pill to help with weight loss has been approved by the U.S. Food and Drug Administration (FDA), and it moved ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

(CNN) — A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In ...

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) ...

The daily pill, called Foundayo, is the second oral GLP-1 product to reach the market over the past few months.

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic ...