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…
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…
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…
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…
On November 20, 2020, biopharmaceutical company RedHill Biopharma Ltd. announced the initiation of a Phase 3 clinical trial to study the orally administered RHB-204. The drug is designed to treat…
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…
According to a story from PR Newswire, new international treatment recommendation guidelines have recently been updated for nontuberculous mycobacterial (NTM) lung disease. The update pertains to a variant known as Mycobacterium…
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