The U.S. Food and Drug Administration (FDA) has faced an unusual convergence of political, scientific, legal and operational pressures in recent months, as it balances public health demands with ...

Please provide your email address to receive an email when new articles are posted on . The FDA found “serious violations” of postmarketing adverse drug experience regulations at Novo Nordisk in 2025.

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. with a fresh draft guidance proposing more changes to streamline development of the cheaper biologic copies.

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...

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 ...

Is the White House putting a leash on Food and Drug Administration vaccine chief Vinay Prasad? Americans can hope so after the agency on Wednesday walked back Dr. Prasad’s startling summary refusal ...

Food and Drug Administration Commissioner Marty Makary told CNBC that his view is that "everything should be over the counter" unless a drug is unsafe, addictive or requires monitoring. He said the ...

Moderna said Wednesday the Food and Drug Administration changed course and will review an amended application for its new flu vaccine, a week after rejecting the original submission and fueling ...

Moderna's shares close up 6% Moderna to conduct post-marketing study in older adults FDA decision expected by August 5 Feb 18 (Reuters) - Moderna said on Wednesday the U.S. Food and Drug ...

The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said ...

Sen. Bill Cassidy (R-La.) on Tuesday unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on the agency to reform some of its practices and embrace innovations in ...

Ana Santos Rutschman does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations ...