News

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.
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 ...
FOX 8 News24m
Vending machine food in Ohio recalled: Here’s what not to eat
Several food items sold in vending machines throughout Ohio, northern Kentucky, and eastern Indiana are being recalled due to ...
BioPharma Dive18h
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 ...
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 ...
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 ...
Food Safety News6h
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 ...
New HIV drug hailed, but can SA afford it?
Lenacapavir is available in both oral tablet form and as subcutaneous injections. It is available as oral tablets and ...
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 ...