FDA Drug Safety Suspensions

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FDA, Sarepta and Elevidys

FDA opens probe into mysterious death linked to gene therapy

The U.S. Food & Drug Administration announced Friday that it has launched an investigation into the death of an 8‑year‑old boy who received Elevidys, the gene therapy developed by Sarepta Therapeutic...

· 20h

FDA Probes Death of Patient on Sarepta's Elevidys, Partner Roche Says Death Unrelated to Therapy

TipRanks on MSN · 16h

FDA investigating death of child who received Sarepta’s Elevidys

· 4h

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics ( NASDAQ: SRPT) have drawn regulatory scrutiny on the viral vector used in the company’s gene therapy platform tech...

STAT · 1d

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

· 1d

EU panel declines backing Sarepta-Roche gene therapy for Duchenne

BioSpace4d

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, noting the need to maintain a good working relationship with the regulator.

Makary ally named to key FDA drug post

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary’s pick to be the nation’s top drug regulator.

Pharmaceutical Technology on MSN4d

Sarepta halts Elevidys shipments following FDA pressure

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

5don MSN

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 Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs.

10hon MSN

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 inspection of dark stores. Hygiene Standards According to a MoneyControl report,

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 administration via nasogastric tube (NG-tube) and gastrostomy tube (G-tube) for SPRITAM.

Yahoo2mon

How the FDA's Milk Testing Pause Affects Your Child's Safety

By now, you have likely heard that the Food and Drug Administration (FDA) has suspended its testing procedures for milk in the U.S. But the information that has been dispersed online about this ...