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Exondys 51

This page shows the latest Exondys 51 news and features for those working in and with pharma, biotech and healthcare.

CHMP backs Spark’s Luxturna, but rejects Sarepta again

CHMP backs Spark’s Luxturna, but rejects Sarepta again

Eteplirsen was approved in the US as Exondys 51 in 2016, although the decision came after FDA reviewers recommended that the drug be rejected as the evidence for its benefits was ... which there was no meaningful difference between Exondys and placebo in

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  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Among the noteworthy orphan approvals are Exondys 51 (for the treatment of Duchenne muscular dystrophy, only approved in the US), Darzalex (for the treatment of multiple myeloma, approved in the US

  • Deal Watch February 2017 Deal Watch February 2017

    Licence. 145. Sarepta Therapeutics/ Gilead Sciences. PRV received when EXONDYS 51 was FDA approved for Duchenne muscular dystrophy.

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