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 ...
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.
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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 ...
Merck: FDA to Review Doravirine/Islatravir Regimen in HIV-1 Infection
Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The ...
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 ...
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Inside the staff exodus and tanking morale that threaten Makary’s FDA
The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current ...
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FDA approves garadacimab-gxii as prophylaxis for hereditary angioedema
The FDA has approved garadacimab-gxii for prophylactic use in patients aged 12 years and older with hereditary angioedema, ...
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.
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FDA Draft Guidance Illuminates MDS Drug Development Pathways
Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...
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 ...
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.