The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...

The U.S. Food and Drug Administration has determined commonly used oral phenylephrine is "not effective" and has proposed its removal from over-the-counter nasal decongestants. Weight-loss ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

RFK Jr., a lawyer-politician, could replace lawyer-politician Xavier Becerra as Secretary of Health and Human Services. Or ...

The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from ...

This approach enables an ongoing dialogue between the regulatory body and drug developers. Expediting the review process ...

Orphan drug status, a status designated by the Food and Drug Administration (FDA), gives companies researching cures for rare diseases a seven-year window of exclusive marketing rights post ...

The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

In 1982 Food and Drug Administration approved Humulin, Eli Lily’s recombinant insulin made from Genentech’s specially modified bacteria. It was the first drug produced through recombinant DNA ...

On October 29, 1959, the pharmaceutical company G.D. Searle filed an application with the U.S. Food and Drug Administration (FDA) to license their drug Enovid for use as an oral contraceptive.

The Food and Drug Administration approved use of a naloxone nasal spray without a prescription last year, a move the agency said was designed to make the medication readily available in drugstores ...