News

FDA names former pharmaceutical company executive to oversee US drug program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
Makary ally named to key FDA drug post
Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty ...
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 ...
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 ...
Zepto & Blinkit On The Radar Of The Maharashtra Food & Drug Administration For Inspection Of Dark Stores
Zepto and Eternal's quick-commerce arm Blinkit are on the radar of the Maharashtra Food and Drug Administration (FDA) for ...
BioSpace3d
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, ...
SPRITAM® (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration
Aprecia, the global leader in 3DP (three-dimensional print) technology for commercial-scale pharmaceutical manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has approved ...
Why Sarepta's halted drug Elevidys is an issue for investors
Sarepta (SRPT) paused shipments of its top-selling gene therapy drug after the US Food and Drug Administration (FDA) raised safety concerns tied to liver toxicity. Yahoo Finance Senior Reporter ...
Devdiscourse6d
Sarepta Defies FDA Order Amidst Gene Therapy Controversies
Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...
Fierce Pharma3d
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 ...
pharmaphorum5d
Sarepta resists as FDA seeks pause on Elevidys use
Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...
Devdiscourse4d
Sarepta Therapeutics Temporarily Halts Elevidys Shipments in Compliance with FDA Requests
Sarepta Therapeutics Inc has voluntarily paused shipments of Elevidys in the United States. The decision responds to FDA ...