News

How we plan to cut FDA drug approval time by months
Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...
FDA approves new twice-yearly HIV shot. What to know
The FDA approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show ...
FDA approves long-lasting HIV-prevention drug
The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and ...
FDA approves the world's only twice-a-year shot to prevent HIV
The U.S. Food and Drug Administration has approved the world’s only twice-a-year shot to prevent HIV. (Scripps News) ...
FDA approves HIV prevention drug taken as twice-yearly injection
Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...
The FDA Approves Powerful HIV Prevention Drug
But the Trump administration’s cuts to HIV programs in the U.S. and abroad could undermine the drug’s rollout.
FDA approves first twice-yearly injection that prevents HIV infection
The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent ...
FDA approves twice-a-year injection for HIV prevention
A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug ...
FDA to offer faster drug reviews to companies promoting 'national priorities'
The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...
US FDA approves Gilead's twice-yearly injection for HIV prevention
The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir, a twice-yearly injection, for ...
FDA Offers Speedier Approvals to Drug Companies Aligning With 'National Priorities'
The initiative, referred to as the Commissioner's National Priority Voucher program, allows drug developers to participate in ...