News

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 ...
FDA approves shot that protects dogs from fleas and ticks for 8-12 months
The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...
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 ...
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 ...
FDA Offers to Trade Faster Drug Reviews for Lower US Prices
Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...
FDA Commissioner: ‘We want to focus on food’
“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...
Pharmabiz8h
US FDA grants orphan drug designation to Klotho Neurosciences’ KLTO-202 to treat amyotrophic lateral sclerosis
US FDA grants orphan drug designation to Klotho Neurosciences’ KLTO-202 to treat amyotrophic lateral sclerosis: New York Saturday, July 12, 2025, 15:00 Hrs [IST] Klotho Neurosci ...
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 ...
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 approves gradual dosing for Lilly Alzheimer's drug
The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...
STAT1d
Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...
The New York Times4d
Food and Drug Administration - The New York Times
News about Food and Drug Administration, ... The U.S. health secretary said people should have access to experimental therapies including unregulated uses of stem cells.