FDA Grants Rare Pediatric Disease Designation to 177Lu-omburtamab-DTPA for Medulloblastoma
Y-mAbs Therapeutics, Inc., a commercial-stage biopharmaceutical company concentrated on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer; ...
U.S. FDA has granted NuCana Fast Track Designation for Acelarin® for the Treatment of Biliary Tract Cancer.
Acelarin (NUC-1031), which is currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer, has been granted Fast Track desig ...
FDA Approval for Zanubrutinib in Waldenstrom macroglobulinemia (WM)
According to BeiGene, the drug's manufacturer, the U.S. FDA has approved zanubrutinib (Brukinsa) capsules to treat adult patients with Waldenstrom macroglobulinemia (WM), a rare non-Hodgkin lymphoma. ...
Moderna Announces First Patient Dose in mRNA-3705 Phase 1/2 Study for Methylmalonic Acidemia (MMA).
Moderna, Inc., a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that the first patient had been enrolled in the Phase 1/2 study evaluat ...
Alkermes Receives U.S. FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Alkermes plc today announced that the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (nemvaleukin), has been granted Fast Track designation by ...
U.S. FDA Grants Orphan Drug Designation to Tesomet In Hypothalamic obesity (HO)
Saniona, a clinical-stage biopharmaceutical company focused on rare diseases, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) to treat hypothalamic obesity (HO) ...