News

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 ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
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 medicines that it later cleared.
US FDA publishes 200 rejection letters in transparency push
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.
Drug Store News3h
GoodRx releases analysis on 2025 FDA generics, brand drug approvals
A growing disconnect remains between what generics are approved and what are actually accessible, GoodRx said.
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
Medscape6h
FDA Issues Early Alert for Medtronic pH Monitoring Capsules
Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...
STAT34m
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
Managed Healthcare Executive4m
FDA Accepts NDA for Investigational HIV Regimen, Doravirine/Islatravir
If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, ...
FDA study links high consumer CBD doses to liver enzyme elevations
FDA researchers report that the upper end of reported consumer use (~400mg of daily CBD intake) of cannabidiol (CBD) may ...
After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...