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Sarepta, Elevidys and FDA

Reuters on MSN · 12h

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' muscular disorder gene therapy Elevidys.

Bloomberg on MSN · 11h

FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

EconoTimes · 10h

FDA Probes Death of 8-Year-Old Linked to Sarepta’s Elevidys Gene Therapy

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta Therapeutics (NASDAQ: SRPT) gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD).

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Fierce Pharma1d

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 ...

EMA Says No to Duchenne Gene Therapy Elevidys

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

Fierce Biotech23h

'We will crack gene therapy': Elevidys fallout doesn't dent Roche's hopes for modality

Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved ...

4d

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

11h

Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...

Pharmalittle: We’re watching Europe moving to reject Elevidys, a FDA panel on SSRI risks, and more

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

2d

InnovationRx: Sarepta Blinks In Showdown With FDA

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

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