NUZYRA for NTM Lung Disease from MAC Earns Fast Track Designation
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NUZYRA for NTM Lung Disease from MAC Earns Fast Track Designation

  In the United States, during the drug development and approval process, drug developers are able to request Fast Track designation. This process is designed to facilitate and expedite the…

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Epetraborole Granted Orphan Drug Designation for NTM Lung Disease
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Epetraborole Granted Orphan Drug Designation for NTM Lung Disease

In a news release from February 16, 2022, clinical-stage biopharmaceutical company AN2 Therapeutics, Inc. ("AN2") shared that its therapy epetraborole was granted Orphan Drug designation for the treatment of non-tuberculous…

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First Patient Enrolled in NUZYRA Trial for NTM Lung Disease

On October 18, 2021, biopharmaceutical company Paratek Pharmaceuticals, Inc. ("Paratek") shared via news release that the first patient had enrolled in a Phase 2b clinical trial. Within the trial, researchers…

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Omadacycline for NTM Lung Disease Earns Orphan Drug Status
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Omadacycline for NTM Lung Disease Earns Orphan Drug Status

In the United States, Orphan Drug designation is granted to drugs or biologics intended to treat patients with rare conditions, defined as affecting fewer than 200,000 Americans. As incentives, drug…

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CF Foundation Awards Over $2 Million for Cystic Fibrosis Treatment Development
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CF Foundation Awards Over $2 Million for Cystic Fibrosis Treatment Development

The Cystic Fibrosis Foundation is dedicated to finding a cure for the rare, genetic disorder. They fund more CF research than any other organization, and their latest effort is a…

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NTM Lung Disease Treatment ARIKAYCE Given European Marketing Authorization
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NTM Lung Disease Treatment ARIKAYCE Given European Marketing Authorization

Early on October 28, 2020, Insmed Inc. ("Insmed") announced that it received Marketing Authorization from the European Commission for ARIKAYCE. This therapy is designed for adult patients with nontuberculous mycobacterial…

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Interim Results from Phase 2a Trial for Nontuberculous Mycobacterial Lung Disease Bring Hope

Nontuberculous mycobacterial (NTM) lung infection occurs when someone inhales nontuberculous mycobacteria from the environment. There are various types of this bacteria, giving NTM different forms. But in all types of NTM,…

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Arikayce® Granted Accelerated Approval by the FDA for the Treatment of MAC Lung Disease
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Arikayce® Granted Accelerated Approval by the FDA for the Treatment of MAC Lung Disease

A new drug designed to treat MAC lung disease as part of a combination antibacterial drug regimen in adults with limited treatment options has been granted Accelerated Approval by the…

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