Exposure to this product may cause temporary or medically reversible adverse health consequences, according to the FDA.

The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, is working to hire a researcher and friend who ...

March 4 () - PepGen said on Wednesday that the U. Food and Drug Administration has placed ‌a partial clinical hold on its mid‑stage trial of ‌a rare muscle disease drug, sending its shares plunging ...

The FDA’s effort to crack down on compounded versions of popular GLP-1 weight-loss drugs has sparked backlash from patients and compounding pharmacies over concerns about access and ...

The FDA's request, intended to conclusively determine the therapy's potency, has raised concerns the trial would be both unethical and impractical.

A new Environmental Working Group report says companies used a regulatory loophole known as “generally recognized as safe” to ...

Savannah Chrisley is facing scrutiny from federal regulators over the wording on her prescription weight loss website. The 28-year-old reality star received a warning letter from the Food and Drug ...

The FDA has outlined a proposed approval pathway for customized drugs and gene-editing therapies designed for rare and hard‑to‑treat diseases.

Chicken dog treats sold in five states are being recalled because the bags may be contaminated with Salmonella. The U.S. Food ...

Durham-based BioCryst Pharmaceuticals Inc. is advancing care for children living with hereditary angioedema (HAE) as it ...

Increased demand for estrogen patches, particularly twice weekly doses, are in short supply nationally, causing delays for patients in Greater Boston.

The agency zeroed in on claims that compounded GLP-1 drugs are comparable to approved medicines. Elsewhere, a blood pressure drug topped Wall Street expectations and a Merck deal paid dividends.