The US Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above.

1. U.S. FDA grants approval for Jivi antihemophilic factor (recombinant), PEGylated-aucl in pediatric patients 7 to under 12 years of age with hemophilia A (congenital factor VIII deficiency).

The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

WASHINGTON (AP) — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.

The FDA expanded the approval of Moderna’s RSV vaccine, extending the license to include more adults and giving the company a welcome win.

GILD wins FDA approval for Yeztugo, the first and only twice-yearly injectable PrEP for HIV prevention in the United States.

Washington — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious ...

Galdieria extract blue, butterfly pea flower extract and calcium phosphate are three food colors from natural sources the FDA has approved for use in food.

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should be targeted by updated versions of the vaccines.

FDA’s additional request for placebo-controlled trials in people ages 50 to 64 is based on inconsistent lower age limits in other countries’ COVID-19 booster recommendations, Prasad said.

Pfizer’s drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical ...