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

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 announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

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.

From Washington to Wall Street, it's a crazy time for biotech. But as Ultragenyx Pharmaceutical Inc. celebrates its 15th ...

Donald Trump's healthcare revamp, emphasizing generics and biosimilars, could boost Indian drug makers, who already supply 40 ...

The food and beverage industry faces significant regulatory change as HHS Secretary Robert F. Kennedy Jr. directs FDA to ...