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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 ...
Moderna’s Covid Shot Fully Approved by FDA for Use in Kids
US regulators approved Moderna Inc.’s Covid vaccine for children, but for a narrower group than before, continuing Robert F.
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.
Medscape4h
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 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.
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 ...
Drug Store News55m
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.
CURE38m
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 ...
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 ...
BioPharma Dive19m
AbbVie to pay $700M for trispecific drug from Ichnos Glenmark
The deal hands AbbVie a drug that’s shown early promise in multiple myeloma and may be useful treating other cancers and ...
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 ...
FDA Issues Highest Risk Warning For Cucumber Recall
Fuentes Farms LLC announced a voluntary recall of 71 boxes of fresh cucumbers on June 13 due to potential salmonella ...