EMA validates Santhera’s Puldysa MAA
Santhera expects an opinion by the CHMP around mid 2020.
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Tag: Puldysa
MHRA renews EAMS scientific opinion for Puldysa in DMD
The drug has been available in the UK through EAMS since June 2017.
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Santhera submits MAA to EMA for Puldysa
The company is seeking conditional marketing authorisation (CMA) for patients with DMD who are not using glucocorticoids.
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