Steep cuts at the Food and Drug Administration might slow down drug approvals vital to the biopharma industry.

Fact checked by Nick Blackmer Compounded versions of semaglutide, the active ingredient in weight loss drugs like Ozempic and ...

Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.

Milestone Pharmaceuticals said on Friday the U.S. health regulator had declined to approve its nasal spray to treat a type of ...

Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.

Americans pay far more for GLP-1 drugs than citizens in other wealthy nations. If Dr. Marty Makary, the new FDA commissioner, ...

After months of back and forth and uncertainty related to efforts under the new Trump Administration to reduce the size of the federal ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

For decades, the United States has led the world in pharmaceutical innovation – developing drugs that combat cancer, heart ...

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the ...

The versions affected are called compounded medications, which have the same active ingredients as the name brands. The ...

With crucial lessons learned from the manufacturing shortages of injectable GLP-1s, experts say securing adequate supply for ...