Previously, garadacimab was granted an orphan drug designation as a therapy for hereditary angioedema by both the FDA and EMA.
FDA Updates
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The approval marks the first for an alternative to platinum-containing chemotherapy.
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Belzutifan (Welireg; Merck) demonstrated superior progression-free survival compared to everolimus in advanced renal cell carcinoma.
The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.
Officials from the FDA have granted Geron Corporation’s imetelstat fast track designation for adult patients with intermediate-2 or high-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.
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