US Food and Drug Administration breakthrough therapy designation (BTD) awards were announced for three products in the past week, for an antifungal for patients with invasive mold infections, a treatment for a rare genetic primary immunodeficiency disease and a second-line therapy regimen for hepatocellular carcinoma.
Two of the BTD sponsors are new to the expedited review pathway: the British and Austrian antifungal biotech F2G Ltd. and the American rare disease specialist X4 Pharmaceuticals Inc.
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