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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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UCB’s Nayzilam Nasal Spray Wins U.S. FDA Approval

UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.

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ViiV Submits NDA for Once-Per-Month HIV Injectable

HIV-focused ViiV Healthcare submitted a New Drug Application (NDA) to the Food and Drug Administration for potential approval of the company’s investigational combination treatment for HIV-1.

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Johnson & Johnson wins U.S. FDA approval for bladder cancer drug

Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.

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Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).

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Novo Nordisk submits diabetes pill for U.S. approval

Novo Nordisk submitted the company’s oral semaglutide drug, a pill that management hopes will transform the diabetes market, for approval in the United States.

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Eton Pharmaceuticals Submits NDA for DS-200

Eton Pharmaceuticals Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the injectable hospital-use product candidate DS-200 via the Rolling Review process.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!


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