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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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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...

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Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
Sarepta Refused FDA’s Request to Halt Elevidys Shipments
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
A 51-year-old man died last month after receiving an experimental gene therapy developed by Sarepta Therapeutics for an ultra-rare form of muscular dystrophy, a company spokesperson confirmed Thursda...

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Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
FDA to ask Sarepta to stop shipping Duchenne gene therapy
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.

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STAT · 1d
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
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.
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Synthetic Psilocybin nears FDA review, signaling a potential shift in American mental healthcare
Supporters believe that FDA approval will make the drug more accessible. Right now, traditional psilocybin therapy offered at healing centers in the state is not covered by insurance.
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."
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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 antipsychotic drug in combination with Viatris' antidepressant Zoloft for treating adults with PTSD.
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.
US FDA Advisers Vote Against Otsuka's PTSD Combination Treatment
(Reuters) -The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's drug when used in combination with Viatris' Zoloft for the treatment of adults with PTSD.
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.
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