Page 16 - சந்தைப்படுத்தல் அங்கீகாரம் விண்ணப்பம் News Today : Breaking News, Live Updates & Top Stories | Vimarsana

BioMarin: EMA Grants Accelerated Assessment For Review Of Valoctocogene Roxaparvovec WASHINGTON (dpa-AFX) - The European Medicines Agency or EMA has granted its request for accelerated assessment of valoctocogene roxaparvovec, for adults with severe hemophilia A, BioMarin Pharmaceutical Inc. (BMRN) said in a statement. Accelerated assessment reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). A CHMP opinion is expected in the first half of 2022. BioMarin said it plans to submit a Marketing Authorization Application (MAA) for valoctocogene roxaparvovec for the treatment of severe hemophilia A in June 2021.

United statesCommittee for advanced therapiesEuropean medicines agencyDrug administrationBiomarin pharmaceutical incCommittee for medicinal products human useBiomarin pharmaceuticalMedicinal productsHuman useAdvanced therapiesAdvanced therapy medicinal productMarketing authorization applicationBiologics license applicationOrphan drug designationஒன்றுபட்டது மாநிலங்களில்பயோமரின் மருந்து இன்க்