FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad ...

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously reported, the FDA sent letters to Moderna and Pfizer/BioNTech in April ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These are the key takeaways.

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's multibillion-dollar heart drug. A new BMJ investigation reveals data ...

From AI-powered inspections to bold regulatory shifts on dyes and sugar, the FDA has made waves in 2025. Here are the 17 most impactful stories shaping the future of food regulation.

The FDA approved Dupixent for the treatment of adults with bullous pemphigoid, a rare skin disease often uncontrolled with systemic corticosteroids, Sanofi and Regeneron announced. The FDA’s ...

Opinion How we plan to cut FDA drug approval time by months Qualifying manufacturers will be able to submit some data while clinical trials are ongoing.

FDA to offer faster drug reviews to companies promoting ‘national priorities’ The FDA already has a variety of programs designed to speed up drug reviews, but they all have fairly strict ...

U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced ...

The FDA announced a new fast-track approval program for domestic drug developers for projects that are national priorities.

FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.