The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

Fourteen other states also have created e-cigarette registries like Wisconsin's, according to the Public Health Law Center at Minnesota's Mitchell Hamline School of Law.

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...

Release of the requested documents will negatively impact an ongoing inspector general investigation,” a city FOIA officer ...