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Verrica Submits New Drug Application to U.S. FDA

Verrica Pharmaceuticals Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum.

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Kala Pharmaceuticals Receives FDA CRL for KPI-121 0.25% NDA

Kala Pharmaceuticals Inc. received a complete response letter from the U.S. Food and Drug Administration regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

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AbbVie Submits New Drug Application to U.S. FDA for Elagolix

AbbVie announced the submission of a New Drug Application to the U.S. Food and Drug Administration for elagolix, an investigational GnRH antagonist for the management of heavy menstrual bleeding associated with uterine fibroids in women.

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Foamix Submits New Drug Application to U.S. FDA for FMX103

Foamix Pharmaceuticals Ltd. announced that the company submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older.

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FDA Accepts Correvio’s Refiling of Brinavess NDA

Correvio Pharma Corp. announced that the U.S. Food and Drug Administration accepted for review the resubmitted New Drug Application (NDA) for the antiarrhythmic drug Brinavess.

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FDA Advisory Committee Cancels Review of Intra-Cellular’s Schizophrenia Drug

Intra-Cellular Therapies shares fell after the company announced that the FDA canceled the advisory committee meeting to discuss the New Drug Application for the schizophrenia drug lumateperone.

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FDA Accepts New Drug Application for RedHill’s Talicia

RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.

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Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. FDA in 2019

Gilead Sciences announced that a path forward was established to submit a New Drug Application in 2019 for the investigational oral, selective JAK1 inhibitor filgotinib as a rheumatoid arthritis treatment.

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Zogenix to Proceed with Resubmission of Fintepla NDA

Zogenix Inc. intends to resubmit the company’s New Drug Application for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in third-quarter 2019.

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Vertex to file for U.S. approval of CF therapy in 2019

Vertex Pharmaceuticals Inc. will apply for regulatory approval during 2019 for the company’s triple combination of drugs to treat the life-shortening genetic condition cystic fibrosis.

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