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’
“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...
‘A national movement’: More than a dozen states consider laws around menopause care and training for doctors
A wave of menopause-related legislation has been introduced across the United States this year, leading to possible shifts in ...
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.
Columbia University trustee calls on board to comply with Trump administration demands
A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...
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 ...
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 ...
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 ...
Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
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 Food and Drug Administration (FDA).
Commentary: Cheap drugs from Canada can’t make America healthy
Florida’s importation program hasn’t brought in a single Canadian drug. It’s not cost-effective and it could be dangerous.
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 ...