Peripheral Nerves Archives

U.S. FDA Approves Panzyga for Treatment of Adults with CIDP

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), FDA, Intravenous Immunoglobulin (IVIg), Peripheral Nerves, Pfizer, Rare Disorders, Supplemental Biologics License Application, Therapeutics

The U.S. Food and Drug Administration approved Pfizer Inc.’s supplemental Biologics License Application for Panzyga to treat adult patients with a rare neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP).

Acceleron Abandons Charcot-Marie-Tooth Program After Trial Failure

Business, Charcot–Marie–Tooth Disease (CMT), Clinical Trials, Dental, Erythroid maturation agents, Hematology, Neurological Disorders, Peripheral Nerves, R&D

Cambridge, Massachusetts-based Acceleron Pharma announced that the company’s Phase II clinical trial of ACE-083 in patients with Charcot-Marie-Tooth disease (CMT) failed to show functional improvement.

Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device

Breakthrough Devices Program, FDA, FDA/Regulatory, Medical Devices, Peripheral Nerves

Checkpoint Surgical Inc. – a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair – received Breakthrough Device designation from the U.S. Food and Drug Administration for the Checkpoint brief electrostimulation therapy (BEST) system.