News

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
BioSpace5d
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
Fierce Pharma3d
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
FDA reaches out to more than 5k eateries over food safety in a year, but hygiene remains a concern
Pune: A string of recent food safety violations at popular eateries in the city has turned the spotlight onto lax sanitation ...
Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug
Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...
Pune: After Goodluck Café, FDA Now Suspends License Of Another Famous Restaurant Over Cockroach Found In Soup
Just days after suspending the license of the well-known Goodluck Café, the Food and Drug Administration (FDA) has taken ...
Fierce Pharma6d
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
FDA suspends Cafe Goodluck’s licence over lack of hygiene
Pune: The Maharashtra Food and Drug Administration (FDA) has issued a notice of licence suspension to Cafe Goodluck on FC ...
Devdiscourse5d
Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...
FDA suspends licence of Pune's famous 'Cafe Goodluck': Here's everything about the glass controversy
The Maharashtra FDA has suspended the license of Pune's popular Cafe Goodluck due to hygiene and safety concerns. This action ...
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 ...