News

Moderna gets full US approval for COVID shot in at-risk children 6 months and older
The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...
F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
Wegovy and Zepbound prices fall, but access to the obesity drugs still isn’t guaranteed
Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging ...
BioPharma Dive16h
FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
Food Safety News3h
FDA increases enforcement of regs for imports including seafood, papayas, cantaloupe and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...
STAT3d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
Gilead, Global Fund finalize plan to supply HIV prevention drug to poor countries
Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis and Malaria said on Wednesday they had finalized plans to ...
Arcus Biosciences' Pancreatic Cancer Treatment Gets Orphan Drug Status
Arcus Biosciences announced that the Food and Drug Administration has granted its pancreatic cancer treatment, quemliclustat, with an orphan drug designation. The company said it expects its ongoing ...
FDA updates blood donation guidelines to try and increase number of donors
The U.S. Food and Drug Administration updated its blood donation guidelines. Now, it goes off individual risk assessment ...
Merck Animal Health's Flea-and-Tick Treatment Approved in U.S.
Merck's animal health division received Food and Drug Administration approval for its once-yearly injectable flea-and-tick treatment for dogs. Merck Animal Health said Thursday it expects its Bravecto ...