News

FDA publishes drug rejection letters for 15 Massachusetts biotechs
In a bid to increase transparency, the U.S. Food and Drug Administration has begun publishing the complete response letters ...
FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
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 ...
Palantir founder’s plans for the FDA
Joe Lonsdale, co-founder of the large government contractor Palantir, wants to embed a team of 15 to 20 “elite engineers” ...
BioPharma Dive3h
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 ...
STAT1h
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.
Medscape7h
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 ...
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 ...
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.
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.
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 ...
STAT3d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...