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GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning
Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...
Coffee Pods Recall Triggers Lowest-Risk Warning From FDA
The U.S. Food and Drug Administration raised concerns over ink printing potentially running when exposed to high temperatures.
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Highest risk warning from FDA on chocolate recall; Check if you're affected
The FDA has issued Class I recalls for chocolate products due to undeclared allergens and contamination—posing serious health ...
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FDA panel elevates concerns over antidepressant use during pregnancy
Experts on the panel shared many of the same views around SSRIs, arguing that the risks of the drugs during pregnancy are greater than currently accepted.
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Minor Alert: Coffee Pods Recalled Over Ink Concerns, FDA Issues Lowest-Risk Warning
Your morning coffee ritual is usually a simple pleasure, but a recent recall of certain coffee pods might make you ...
National Consumer Alert on 7-OH Products Posing Significant Dangers
FDA issues warning letters to distributors of food, dietary supplements and unapproved drugs that contain ...
F.D.A. Panel Debates ‘Black Box’ Warning for Antidepressants in Pregnancy
An agency-sponsored forum included critics of psychiatry who believe the drugs can harm a developing fetus. Other experts ...
Nationwide Sausage Recall as Consumer Warning Issued
Kayem Foods Inc. has issued a voluntary recall for more than 24,000 pounds of its Sweet Apple Chicken Sausages.
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments
Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...
Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
Fake weight loss drugs spark alarm: Warning sent to FDA, FTC over counterfeit GLP-1s
New and disturbing concerns about fake GLP-1 drugs are cited in a letter sent to the FDA by Tennessee officials, including Sen. Marsha Blackburn.