News

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
US FDA advisers recommend against Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...
Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...
FDA recalls frozen sprouted beans produced by Sugarland company for links to salmonella outbreak
Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a ...
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 approves Juul e-cigarette and cartridge sales
Officials with the Food and Drug Administration have approved the continued sales of tobacco-flavored e-cigarettes and refill ...
Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes
The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a ...
JD Supra10h
FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may ...
The FDA Announces Recall on Bread Sold at Walmart and Kroger in These States
Lewis Bake Shop is issuing a voluntary recall on their Artisanal Style 1/2 Loaf, which contains undisclosed hazelnuts — a ...
FDA approves new blue food dye derived from gardenia fruit
The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering ...
EatingWell on MSN2d
The FDA Just Approved a New Food Dye, but What Makes It Different?
The FDA just approved Gardenia (genipin) blue, a natural food dye, for certain foods and drinks. They’re also trying to ...
US FDA advisers vote against Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...