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The Scottish Medicines Consortium recommends Novartis’ Kesimpta (ofatumumab) for patients living with relapsing remitting multiple sclerosis (RRMS) firstwordpharma
July 14, 2021
Novartis today announced that eligible patients in Scotland will soon have access to Kesimpta® (ofatumumab), the first self-administered, targeted B-cell therapy for patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined b
Novartis bags EU, UK licences for MS therapy Kesimpta pharmatimes
April 09, 2021
Novartis has received green lights from both the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to market its multiple sclerosis (MS) therapy Kesimpta (ofatumumab).
Novartis Announces Update on FDA Review of Ofatumumab americanpharmaceuticalreview
June 15, 2020
Novartis has received notice from the US Food and Drug Administration (FDA) the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157) ...
Regulators expand review time for Novartis' MS drug pharmatimes
June 05, 2020
US regulators are extending the review time for Novartis' MS therapy ofatumumab.
Novartis Announces New Ofatumumab Data at EAN americanpharmaceuticalreview
June 03, 2020
Novartis announced new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European Academy of Neurology (EAN).
FDA and EMA accept licence applications for multiple sclerosis treatment europeanpharmaceuticalreview
March 04, 2020
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).