Amid the threat of pharmaceutical tariffs from President Donald Trump, recent months have seen multibillion-dollar U.S.

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The Food and Drug Administration has introduced a new AI tool that could expedite the review and approval process for medical ...

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — Lawmakers ...

Two common allergy medications could cause a severe reaction in some people who stop using it. The U.S. Food and Drug Administration (FDA) issued an alert related to cetirizine (Zyrtec) or ...

LOOKING INTO VAX CRYSTAL BALL — The Covid-19 vaccine framework that FDA Commissioner Marty Makary teased last week is expected to drop today, two people familiar with the plan and granted ...

The FDA plans to limit COVID-19 vaccine booster recommendations to those over 65 or with underlying health conditions. FDA officials question the necessity of annual boosters for healthy ...

Previously, the FDA conducted postmarket reviews reactively, typically triggered by citizen petitions or emerging scientific evidence. Now, the agency is implementing a new framework for these ...

May 19, 2025 – The FDA has approved the Novavax COVID-19 vaccine, a protein-based alternative to mRNA shots, with some limits on who can get it. The vaccine, called Nuvaxovid, is mainly ...

The FDA may be poised to ban talc as an ingredient in the products it regulates, including foods, pharmaceuticals, and cosmetics. The agency convened what it called an expert panel on talc on May ...

The Food and Drug Administration (FDA) is warning consumers, distributors and retailers to not eat, sell or serve recently recalled cucumbers as they have been linked to a salmonella outbreak in ...