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Gilenya News
Tascenso ODT (fingolimod) Launched to Meet the Needs of Multiple Sclerosis Patients in the US Left Without Essential Patient Support
Tascenso ODT is available to dispense to US multiple sclerosis (MS) patients Tascenso ODT is bioequivalent to, but not a generic of, Gilenya® (fingolimod) capsules1,2 On March 31st 2023 the Gilenya ...
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being...
FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
May 11, 2018 – The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the...
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection
ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple...
FDA Medwatch Alert: Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection
ISSUE: FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod)....
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose
[UPDATED 05/14/2012] FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional ...
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose
[Posted 12/20/2011] ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot...
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