News

FDA opens probe into mysterious death linked to gene therapy
The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
Mumbai News: FDA Clears MLA Hostel Canteen Food As Fresh But Flags 19 Safety Violations
Mumbai: The food served at the Akashwani MLA Hostel in Churchgate was not stale, according to laboratory tests conducted by ...
Two boys died after a gene therapy. This family won’t give up hope.
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.
Pune’s Iconic Goodluck Café Cleared To Reopen As FDA Revokes License Suspension: All You Need To Know
In good news for patrons of Pune's iconic Goodluck Café, the Maharashtra Food and Drug Administration (FDA) has issued an ...
Fierce Pharma2d
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 ...
Maharashtra Food and Drug Administration clears Pune’s Café Goodluck after hygiene scare
Last Monday, FDA temporarily suspended the license of Cafe Goodluck in Pune due to unhygienic conditions at the restaurant.
Now, customer claims cockroach found in egg bhurji at eway outlet of Cafe Goodluck
Pune: Cafe Goodluck seems to be in trouble yet again after a customer allegedly found a dead cockroach in an egg bhurji that ...
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
Fierce Pharma4d
Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
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 ...