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FDA approves first generics of Gilenya expresspharma
December 09, 2019
The US Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.
FDA approves generics of Novartis multiple sclerosis drug Gilenya pharmaceutical-technology
December 09, 2019
The US Food and Drug Administration (FDA) has approved the first generic versions of Novartis multiple sclerosis drug Gilenya (fingolimod).
Novartis' key multiple sclerosis product Gilenya gets approval in China biospectrumasia
July 20, 2019
Chinese National Medical Products Administration (NMPA) approved Gilenya® for relapsing forms of multiple sclerosis (RMS) for adults and children 10 years and older
Novartis' Gilenya staves off generic challengers⁠—for now⁠—after federal injunction fiercepharma
June 28, 2019
Novartis’ multiple sclerosis med Gilenya is facing U.S. generic challengers on all sides to its blockbuster sales, and the company hoped a court order could stave them off. The Swiss drugmaker got what it asked for—and it might just keep the med at the to
Novartis Announces EU Approval of Gilenya americanpharmaceuticalreview
November 30, 2018
Novartis announced the European Commission (EC) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms
Novartis' Gilenya scores paediatric EU approval for advanced relapsing-remitting MS pharmafile
November 30, 2018
Novartis has announced that Gilenya (fingolimod) has received marketing authorisation from the European Commission for the treatment of relapsing-remitting forms of multiple sclerosis (RRMS) in patients aged between 10 and 17 years old...
EU approves Gilenya for paediatric MS pharmatimes
November 30, 2018
European regulators have approved Novartis’ Gilenya for the treatment of children and adolescents from 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS).
FDA Expands Approval of Gilenya americanpharmaceuticalreview
May 18, 2018
The U.S. Food and Drug Administration (FDA) approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older.