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Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson’s Disease

Supernus Pharmaceuticals receives FDA Complete Response Letter for SPN-830, an investigational apomorphine infusion device for Parkinson's disease. CRL indicates additional review needed for product quality and infusion device master file. No clinical safety or efficacy issues identified.

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Supernus Provides Regulatory Update For SPN-830, FDA Has Issued A CRL In Response To The Co’s NDA For Spn-830 Indicating That The Review Cycle For The Application Is Complete, But That The Application Is Not Ready For Approval In Its Present Form.

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update

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