One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they ...

After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with ...

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in ...

The biotech industry is facing a major hurdle as widespread layoffs at the U.S. Food and Drug Administration (FDA) disrupt the drug development process. Biotech firms—particularly smaller ones—are ...

Like much of the federal government, the Food and Drug Administration ... congressional approval, could shift more of the inspections to states or local officials. The FDA already outsources ...

In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...

The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.

The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among ...

Like much of the federal government, the Food and Drug Administration has faced several program cuts and changes under the ...

Under the Orphan Drug Act ... publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

Rare diseases, often referred to as orphan diseases, affect small patient populations, yet collectively they impact more than ...