fda food and drug administration - Search News

News

FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Associated Press News on MSN · 1h

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 therapy.

The Boston Globe · 1h

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.

U.S. News & World Report · 21h

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 muscular dystrophy patient who received a different, experimental treatment died,

FDA approves JUUL vapes

UPI on MSN · 1d

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 cartridges by Juul Labs.

The Associated Press - Busines… · 1d

Juul can continue selling its tobacco and menthol e-cigarettes, FDA says

WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.

Reuters on MSN · 1d

FDA approves Juul's tobacco and menthol e-cigarettes

The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with heightened regulatory scrutiny,

FDA, GSK and Drug Administration

The Wall Street Journal on MSN · 1d

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 with the FDA.

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 (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

FDA advisers say risks of GSK blood cancer drug outweigh benefits in surprise setback

FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the selected dose

19hon MSN

Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after ...

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 ...

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 ...

4don MSN

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 ...

Results that may be inaccessible to you are currently showing.

Hide inaccessible results