That's a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from GSK, taken every other month.

The Food and Drug Administration approved a twice-yearly shot that prevented HIV infections in 99.9% of the people who received it in large clinical trials.

The FDA’s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna’s existing vaccine.

The U.S. Food and Drug Administration has approved the Sonu Band, an artificial intelligence-enabled, wearable medical device for at-home treatment of moderate-to-severe nasal congestion in ...

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from ...

This approval makes Bio-Thera the seventh company to receive FDA approval for an ustekinumab biosimilar, joining Amgen, Alvotech, Samsung, Fresenius, Accord, Biocon, and Celltrion.

Breakthroughs, discoveries, and DIY tips sent every weekday. The FDA has greenlit the first lab-grown fish for public consumption, and it’s already available in a restaurant.

The agency approved the company's lower-dose Covid vaccine for older adults and young people with underlying medical conditions.

The launch of the injection faces potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts.

The Food and Drug administration has approved a new COVID-19 vaccine made by Moderna but with limits on who can use it.

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option. The new vaccine ...