Top neuro stories of January: FDA developments, Medicare proposal limits Aduhelm coverage
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Healio’s most-viewed neurology stories in January highlight several FDA developments, a Medicare proposal to limit Aduhelm coverage and a study on the role of Epstein-Barr virus infection in MS.
FDA gives breakthrough designation to blood-based test for early prediction of Alzheimer’s
The FDA has granted breakthrough device designation to Diadem U.S. Inc. for AlzoSure Predict, its blood-based test for early prediction of Alzheimer’s disease. Read more.
FDA grants approval to insomnia drug
The FDA granted approval to Quviviq to treat adults with insomnia. Read more.
Medicare proposal would limit Aduhelm coverage to those enrolled in clinical trials
CMS has proposed a National Coverage Determination decision memorandum specifying “coverage with evidence development” for FDA-approved monoclonal antibodies targeting amyloid for treating Alzheimer’s disease. Read more.
FDA grants final approval for infantile spasm drug
The FDA has granted final approval to Zydus for Sabril, an anticonvulsant used to treat children aged 1 month to 2 years with infantile spasms. Read more.
Epstein-Barr virus may be ‘initial trigger’ of MS
Epstein-Barr virus infection, which causes mononucleosis, may represent a primary cause of MS, according to results of a longitudinal analysis published in Science. Read more.