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FDA Grants Priority Review To AstraZeneca's Efzimfotase Alfa In Hypophosphatasia
Source: Nasdaq
Healthcare & BiotechRegulation & Legislation
Alexion, AstraZeneca's rare-disease unit, said the FDA accepted its Biologics License Application for efzimfotase alfa and granted it priority review. The application covers treatment of patients aged 2 years and older, accelerating the FDA review timeline and representing a positive regulatory catalyst for AstraZeneca's rare-disease pipeline.
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