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NICE expands access for SMA drug Spinraza pharmatimes
May 07, 2021
The UK’s National Institute for Health and Care Excellence (NICE) has extended the clinical eligibility criteria for Biogen’s spinal muscular atrophy (SMA) drug Spinraza following a review of data collected as part of a managed access agreement (MAA).
EMA accepts Astellas/Seagen’s enfortumab vedotin for review pharmatimes
March 29, 2021
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for Astellas and Seagen’s enfortumab vedotin.
EMA validates Pfizer and OPKO’s somatrogon marketing application for review pharmaceutical-business-review
March 04, 2021
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.
EMA accepts Arvelle’s cenobamate MAA pharmatimes
March 30, 2020
Arvelle Therapeutics’ Marketing Authorisation Application (MAA) for cenobamate has been accepted by the European Medicines Agency (EMA).
Orchard Therapeutics Announces MAA Filing of Metachromatic Leukodystrophy Treatment americanpharmaceuticalreview
December 30, 2019
Orchard Therapeutics announced the European Medicines Agency (EMA) has validated the company’s Marketing Authorization Application (MAA) for OTL-200 ...
Emmaus Life Sciences Announces Withdrawal of MAA to European Medicines Agency americanpharmaceuticalreview
September 23, 2019
Emmaus Life Sciences announced the withdrawal of its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Xyndari™ (glutamine) for the treatment of sickle cell disease.
Santhera submits MAA to EMA for Puldysa pharmatimes
May 28, 2019
Santhera Pharmaceuticals has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Puldysa (idebenone) in duchenne muscular dystrophy.
Application to EMA filed for the approval of oral semaglutide europeanpharmaceuticalreview
April 30, 2019
It has been announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMA) for oral semaglutide.
Janssen submits MAA to EMA for esketamine nasal spray pharmaceutical-technology
October 12, 2018
Johnson & Johnson’s Janssen Pharmaceutical Companies has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its esketamine nasal spray.