New Drug Application (NDA) News and Research

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SCYNEXIS announces positive results from first interim efficacy analysis of FURI study

SCYNEXIS announces positive results from first interim efficacy analysis of FURI study

FDA and EMA accept Novartis' regulatory application for siponimod to treat SPMS in adults

FDA and EMA accept Novartis' regulatory application for siponimod to treat SPMS in adults

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

CFDA accepts Ascletis’ NDA for first all-oral HCV treatment

CFDA accepts Ascletis’ NDA for first all-oral HCV treatment

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Ocular Therapeutix resubmits NDA for DEXTENZA

Ocular Therapeutix resubmits NDA for DEXTENZA

Celgene announces regulatory information about investigational compound for relapsing multiple sclerosis

Celgene announces regulatory information about investigational compound for relapsing multiple sclerosis

FDA to expedite orphan drug processing queues

FDA to expedite orphan drug processing queues

LimTox online software tool provides information on drug hepatotoxicity

LimTox online software tool provides information on drug hepatotoxicity

FDA issues Complete Response Letter for Sunovion’s New Drug Application to treat COPD patients

FDA issues Complete Response Letter for Sunovion’s New Drug Application to treat COPD patients

Investigational compound for treating indolent lymphomas shows positive results in phase II clinical study

Investigational compound for treating indolent lymphomas shows positive results in phase II clinical study

NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

CTI BioPharma announces Q4 and FY 2015 earnings

CTI BioPharma announces Q4 and FY 2015 earnings

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute

Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute

FDA approves non-alcoholic Docetaxel Injection

FDA approves non-alcoholic Docetaxel Injection

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

Sanofi seeks FDA NDA approval for once-daily fixed-ratio combination of insulin glargine and lixisenatide

TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan

TaiGen releases Taigexyn (nemonoxacin) capsules in Taiwan