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The framework consists of 2 documents that expand on the agency’s plans for its risk-based approach for describing drugs, devices, and biologics, including those designated as regenerative medicine advanced therapies.

Neuromodulation and Stimulation Devices Offer Additional Options to Patients With Headache Disorders
As many patients with migraine and other disorders are resistant to currently available options, this increase in device development has brought forward additional path­ways to treatment for patients.

In addition to tremor-dominant Parkinson disease and essential tremor, focused ultrasound has the potential to be used in a number of conditions, according to the chief of the Neurology Service at the Maryland VA Health Care System.

Preliminary results show that the whole genome information can be used to assess the association between predicted gene expression in different parts of the brain and sleep, suggesting where brain genes are expressed matter for variability in sleep.

The professor in the Department of Neurology at Klinikum Wels-Grieskirchen, in Wels, Austria, spoke about the anti-CD20 antibody and its potential to treat patients with MG.

The therapy, which has a PDFUA date of Aug. 19, 2019, is being studied in an ongoing phase 3 study.

The chief medical officer of Cytokinetics spoke about the promise that the investigational fast skeletal muscle troponin activator holds as a potential treatment for spinal muscular atrophy.