Exondys 51

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

Summit plunges after Duchenne disappointment

Sarepta's investment in the field has been possible thanks to the FDA’s approval of the first US-approved Duchenne drug, Exondys 51, in 2016, despite controversies over its efficacy. ... The field is marked by the curiosity of the EMA having approved

Latest news

Sarepta soars on positive Duchenne data

it’s already a player in DMD therapy with its exon-skipping Exondys 51 (eteplirsen) therapy – approved in the US but not the Europe – but that drug is only suitable for
Daily Brief: ASCO latest, Europe cautions on immunotherapy, rejects Duchenne treatment

Europe still unconvinced by Duchenne treatment Exondys. Finally, the CHMP has confirmed its earlier decision to refuse marketing authorisation for Sarepta’s Exondys(eteplirsen). ... roundly rejected this drug, but approved Exondys.
FDA reviewer unimpressed with PTC’s Translarna

that the firm was emboldened by the FDA’s approval last year of another DMD therapy from Sarepta - Exondys 51 (eteplirsen) - after Janet Woodcock, head of the agency’s Center for
Sarepta eyes FDA filing for DMD drug golodirsen after positive trial

The exon-skipping drug raised functional dystrophin levels. Sarepta is preparing to file a follow-up to its Duchenne muscular dystrophy (DMD) treatment Exondys 51 that seems to have greater efficacy. ... normal from an average baseline level of 0.095% of
FDA approves first steroid for Duchenne muscular dystrophy

The agency granted orphan and priority review status for the drug, which is the second DMD treatment to be approved in the US after Sarepta Therapeutics' exon-skipping therapy Exondys 51 ... Marathon's chief executive Timothy Cunniff, alluding to the

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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

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

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Approximately 0 fully matching, plus 2 partially matching documents found.

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