The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application.

On Friday, the F.D.A. approved a new antibiotic, zoliflodacin, a day after an article published in The Lancet reported that a clinical trial had found that a single oral dose of the drug was safe and effective against gonorrhea. The disease infects more than 80 million people each year and can have serious health implications.

The U.S. Food and Drug Administration has approved an oral pellet formulation of BioCryst Pharmaceuticals' drug to prevent hereditary ‍angioedema attacks in children aged 2 to under 12, the company said on Friday.

In her nine months as scientific adviser to U.S. Food and Drug Administration Commissioner Marty Makary, Tracy Beth Høeg’s track record has raised questions about her ability to oversee drug regulation without bias,

Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, and the treatment and control of cattle fever tick in

Food and Drug Administration officials have opened a safety review of two injectable drugs used to protect babies and toddlers from RSV, the respiratory virus that sends thousands of American children to the hospital each year.

Zoliflodacin, which will be marketed under the name Nuzolvence, is the first new drug to uniquely target gonorrhea infections in decades, and the first developed as part of a public-private partnership.

IL, and U.S. Rep. Rosa DeLauro, D-CT, have reintroduced the Federal Food Administration Act. The act is designed to streamline the U.S. food safety system by consolidating the Food and Drug Administra

The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a severe form of fatty liver disease in drug trials, the agency said on Monday.

For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is growing harder to treat,

Innoviva received approval from the Food and Drug Administration for Nuzolvence, a treatment of gonorrhea. Nuzolvence has been approved as a single-dose oral medication to treat uncomplicated urogenital gonorrhea in patients 12 years and older, the biopharmaceutical company said Friday.