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BioPharma Dive58m
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 ...
FDA issues highest risk warning for vegetable recall
And Go Concepts LLC announced a voluntary recall for a range of vegetable products on May 27 due to potential listeria ...
FDA issues highest risk warning after mushrooms recalled nationwide
The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...
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 ...
FDA names former pharmaceutical company executive to oversee US drug program
The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr. George ...
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.
Science News2d
U.S. FDA may nix black box warning on some menopause estrogen treatments
Experts worry the warning on vaginal estrogen menopause treatments is doing more harm than good and is not supported by science.
FDA Issues Risk Warning for Sunscreen Recall in Multiple States
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...
Healio3d
FDA panel calls for label changes, more education on menopausal hormone therapy
Members of an FDA expert panel discussed reassessing boxed warnings for menopausal HT and how to better educate patients and ...
WholeFoods Magazine6d
FDA Issues Warning Letters to Companies Selling 7-OH Products
Based on peer-reviewed research from leading experts, highly concentrated or semi-synthetic 7-OH products pose significant ...
FDA staff flags eye safety risks for GSK's blood cancer drug
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug Blenrep, when used in combination with other treatments, may cause eye damage in ...
FDA Blueberry Recall Has Now Turned Deadly: Who Are The Most Vulnerable? Here's What You Need To Know
US blueberry recall upgraded to deadly risk due to listeria. UK consumers urged to check imports and watch for symptoms.