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FDA News Briefs for Wednesday, May 29, 2019

May 29, 2019

These Food and Drug Administration (FDA) developments came in this week:

 

FDA Approves NovoTTF-100L System for Malignant Pleural Mesothelioma

The FDA has approved the NovoTTF-100L System (Novocure Ltd.) to be used in combination with dual chemotherapy as first-line therapy for patients with unresectable locally advanced or metastatic malignant pleural mesothelioma. The NovoTTF-100L System is a portable device that delivers alternating electrical fields to the region of the tumor; it is used in the home setting. More Information.  

 

FDA Clears New Device for Acute Treatment of Migraine

The FDA has granted a de novo marketing clearance for the the Nerivio Migra device (Theranica Bio-Electronics Ltd.), a wearable neuromodulation device for acute treatment of migraine headache with or without aura in adult patients. More Information.

 

FDA Expands Approval for Jakafi

The FDA has approved a supplemental new drug application for Jakafi (ruxolitinib; Incyte Corporation), a kinase inhibitor for the treatment of steroid-refractory acute graft-versus-host disease in patients 12 years of age and older. Jakafi was previously approved for intermittent or high-risk myelofibrosis and polycythemia vera. More Information.

 

EV1000 Clinical Platforms Recalled

Edwards Lifesciences LLC has issued a recall of EV1000 Clinical Platforms due to potential fluid leakage into the AC power outlet that may result in device malfunction or fire. The FDA identified this as a Class I recall, as it may cause serious injury or death. More Information.