Tag Archives: MAA

March, 2016

2 March
Baxalta Submits MAA to the EMA for its Hemophilia A Treatment

BANNOCKBURN, Ill.–(BUSINESS WIRE)– Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ADYNOVI, an extended circulating half-life recombinant Factor …
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4 December
Amgen Submits First Biosimilar Marketing Authorization Application to EMA for ABP 501

THOUSAND OAKS, Calif., Dec. 4, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, a biosimilar candidate to Humira®(adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents …
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10 June
BioMarin Files for Approval of its Duchenne Muscular Dystrophy Drug in Europe

BioMarin Pharmaceutical Inc. has filed for European approval of its investigational drug for a rare, genetic disorder that causes progressive muscle wasting. The company said that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for drisapersen, an investigational antisense oligonucleotide drug candidate for the …
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