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 ...

Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as ...

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

Sanofi will commence a Phase I/II trial with its vaccine candidate in the next few days to start generating immunogenicity ...

Novo Nordisk said Thursday that the rampant growth of the U.S.’ compounded drug industry was hurting Wegovy sales, and warned ...

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 ...

Robert F. Kennedy Jr.'s overhaul of federal health agencies will likely impact how Americans get health care, prescription drugs and more.