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 ...
Ginger Beer Recall Update as FDA Issues Highest Risk Warning
Rachel's Ginger Beer issued a voluntary recall for its "Cucumber x Tarragon Ginger Beer" in November last year due to ...
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 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 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 ...
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 Issues Warning Over 'Gas Station Heroin' With Fatal Side Effects
U.S. cases of severe side effects from exposure to tianeptine have increased from 11 in total between 2000 and 2013 to 151 in ...
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) ...
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 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 ...
HIV prevention drug lenacapavir approved by FDA as twice-yearly injection
Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...
New FDA Chief Wants to Fast-Track Some Drugs, Use More AI
FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.