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

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

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 ...

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

The United States has led the world in pharmaceutical innovation for decades by developing drugs that combat cancer, heart ...

The future of American drug innovation is threatened by U.S. regulations that permit knockoff versions of new drugs to be ...

Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...

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

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

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

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