News

FDA to end dozens of 'obsolete' rules for U.S. food items
The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also ...
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 ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
Agri-Pulse3d
FDA continuing talks about shifting food inspection to states
The Food and Drug Administration is developing a plan to shift more food safety inspections over to state partners over the ...
Unpasteurized vs. pasteurized: What to know about food safety
Pasteurization is the process of heating a food product for a certain amount of time to destroy bacteria and viruses present, according to the Centers for Disease Control and Prevention (CDC). Dairy ...
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 ...
Exclusive: 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 ...
Food Safety News3d
FDA wants industry to suggest how to better use recalls for food safety
The Food and Drug Administration is calling on industry to provide input on how to better institute recalls, particularly for food for infants. In a ...
Safety of Foreign-Made Medications in Question After FDA Layoffs
Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.
STAT6hOpinion
A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry
More than 50 biotech leaders and investors are urging the FDA to disregard a methodologically flawed report on mifepristone.
Devdiscourse20h
FDA Scrutiny Intensifies as Sarepta Gene Therapy Faces Dire Setbacks
The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...
FoodNavigator-USA5d
FDA urges infant and children’s food brands to improve recall communications under Operation Stork Speed
FDA is urging manufacturers of infant formula, baby food and children’s nutrition products to sharpen their recall ...