News

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 ...
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 ...
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 ...
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 ...
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 Administration to halt all shipments of its gene therapy.
The Reynolds Center for Business Journalism1d
The FDA lets ‘risky drugs’ into the U.S. market, ProPublica reporter explains their investigation
The team spent 14 months investigating and found that the FDA had allowed more than 150 potentially unsafe drugs in the U.S.
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 ...
MPR1d
FDA Plans to Revoke 52 Food Standards
HealthDay News — The US Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they ...
GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...
Food Business News1d
FDA targets 52 food standards of identity for termination
WASHINGTON — The US Food and Drug Administration aims to revoke 52 standards of identity (SOI) across a swath of food ...
Dairy Reporter1d
FDA to scrap ‘obsolete’ food standards to boost transparency
The FDA proposes to revoke standards for 18 dairy products, including low-sodium cheddar and colby cheese, acidified milk and ...
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 ...