News

FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA Commissioner: ‘We want to focus on food’
Makary, a surgical oncologist tapped by President Trump to serve as the the 27th FDA chief, joined NewsNation on Thursday to ...
Weaver Nut Company chocolate recall under FDA's highest risk level
The FDA recalled some chocolate products by the Weaver Nut Company chocolate, warning about possible serious to ...
BioPharma Dive2d
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 ...
FDA Issues Risk Warning as Apples Recalled in Four States
A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...
Blockbuster long acting flea and tick treatment for dogs coming after FDA approval
A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the ...
US FDA declines to approve Ultragenyx's gene therapy for rare inherited disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
Senate panel clears FDA appropriations
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...
STAT1d
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
ABC4 Utah13h
Utah dentists call on public to submit comments to FDA in support of ingestible fluoride supplements
Fluoride has been shown scientifically for decades to be the best way at combatting tooth decay, and if we pull that away, we ...