News

FDA to Share Rejection Letters Drugmakers Often Keep Secret
The head of the US Food and Drug Administration said the agency will start publishing the rejection letters that companies ...
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 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.
Muffin recall update as FDA warns of potential metal parts in products
Products were distributed in New York, Pennsylvania, Massachusetts, New Jersey, Maryland, Virginia, Washington, D.C., North ...
Medscape1h
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 ...
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / ...
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 ...
Medical groups urge Kennedy, FDA to reexamine broad approval of abortion drugs
Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...
Medical device company receives FDA approval for Parkinson’s treatment
The company completed a clinical trial at nine centers across the U.S., Europe and Asia before it received FDA approval.
STAT2d
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 ...
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
Nationwide Gummies Recall Update as FDA Issues Highest Risk Warning
Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.