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Sarepta Soars After FDA Says Some Patients Can Get Elevidys

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

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 ...

FDA’s Reversal on Gene Therapy Helps My Son

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Fierce Pharma5d

FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

FDA allows Sarepta to resume some Elevidys shipments

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

US FDA recommends removal of hold on Sarepta's Elevidys in some patients

The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...
Just The News3d

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 Pharma5d

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

Sarepta Therapeutics Stock Surges as FDA Allows Elevidys Sales to Resume

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

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 ...
BioSpace5d

Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...