News

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 ...
MiBolsilloColombia on MSN21h
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 ...
BioPharma Dive5h
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.
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.
Soy Carmín on MSN3d
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 ...
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.
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 ...
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.
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 ...
Devdiscourse19h
Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...
Devdiscourse3d
Scrutiny Intensified: FDA Calls Halt on Sarepta's Gene Therapy Amid Safety Concerns
The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...