Order byBest matchMost fresh

FDA asks Sarepta to stop shipping gene therapy

Digest more
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said late Friday it won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient re...

Continue reading

Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
Sarepta tells FDA it won’t halt shipments despite patient deaths
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient r...

Continue reading

FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys
Wall Street analysts have said the third death could amplify patient hesitancy to use Elevidys, given both the therapies use the same delivery vehicle known as adeno-associated virus vector.

Continue reading

FDA to ask Sarepta to stop shipping Duchenne gene therapy
STAT · 18h
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
FDA Issues Risk Warning for Ice Cream Recalled in 23 States
Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes.
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 include "unnecessary" ones.
Explore more
The FDA's Newest Approval Could Have A Major Impact On Your Favorite Foods
Move over, artificial food colors, the FDA just approved gardenia (genipin) blue, a plant‑derived dye to shake up drinks and candies.
FDA panel reassesses hormone therapy warnings in menopause treatments
The Food and Drug Administration is reassessing some warnings given about hormone therapy treatments for menopause that have led to some women avoiding the option, even if it could help them.
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 salmonella outbreak.
FDA Plans to Revoke 52 Food Standards
The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other foods. The FDA has reviewed its portfolio of more than 250 food Standards of Identity to "make sure they are useful, relevant, and serve consumers in the best possible way."
Sarepta's Setback Deepens With Another Gene Therapy Fatality
Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene therapy pipeline this year, further clouding investor confidence despite the company’s recent efforts to provide clarity on its restructuring and FDA label plans.
Feedback