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Sarepta can begin shipping Elevidys therapy

Bloomberg on MSN · 1h

FDA’s Vinay Prasad Exits After Sarepta Gene Therapy Controversy

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his handling of Sarepta Therapeutics Inc.’s gene therapy.

Reuters on MSN · 11d

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration (FDA) reversed its request for a voluntary pause late Monday.

8hon MSN

Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.

Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...

Prasad Out at CBER Following Sarepta Rollercoaster and Conservative Criticism

The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...

Just The News17m

FDA allows distribution of muscular dystrophy drug again after public criticism

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

Fierce Biotech8d

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

Pharmalittle: We’re reading about a new Novo Nordisk CEO, an FDA reversal on Sarepta, and more

Novo Nordisk tapped Maziar Mike Doustdar, its head of international operations, as its new chief executive officer and ...

1d

Healthcare earnings: UnitedHealth delays, Sarepta's FDA probe

UnitedHealth (UNH) delayed its earnings report amid rising medical costs and is now set to report second quarter results on ...

1don MSN

Sarepta Stock Drops After Downgrade and FDA Probe. The Crisis Explained.

The selloff came after the U.S. Food and Drug Administration said late Friday that it was probing the death of an 8-year-old ...

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 ...

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