The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...

Mumbai: The food served at the Akashwani MLA Hostel in Churchgate was not stale, according to laboratory tests conducted by ...

The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients died, the drug’s manufacturer halted dosing under pressure from the FDA.

In good news for patrons of Pune's iconic Goodluck Café, the Maharashtra Food and Drug Administration (FDA) has issued an ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

Last Monday, FDA temporarily suspended the license of Cafe Goodluck in Pune due to unhygienic conditions at the restaurant.

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...