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, 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.
Medscape5h
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 ...
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 Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
Drug Store News2h
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 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 ...
CURE2h
FDA OKs New Test to Match Lung Cancer Patients With Targeted Therapies
The U.S. FDA has approved a new test for patients with lung cancer to match the correct individuals with a targeted treatment ...
Indianapolis Business Journal1h
FDA begins sharing rejection letters drugmakers often kept secret
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
FDA Issues Highest Risk Warning for Nationwide Chocolate Recall
Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.
Klotho Neurosciences stock soars after FDA grants orphan drug status for ALS
Investing.com -- Klotho Neurosciences, Inc. (NASDAQ: KLTO) stock surged 22% after the company announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its ...