PARAMUS, NJ. — NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S Food & Drug Administration (FDA) has granted Fast Track designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA). NS-229...
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CAMBRIDGE, Mass. — Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track product designation to FOG-001 for the treatment of desmoid tumors, reflecting significant unmet need and the potential...
CAMBRIDGE, Mass. — Repertoire® Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to RPTR-1-201 for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic triple-negative breast cancer (TNBC)...
PRAGUE, Czech Republic, BASEL, Switzerland and BOSTON, Mass. — SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SOT106, the company’s potentially best-in-class investigational antibody-drug conjugate (ADC), for the treatment of soft tissue sarcoma, underscoring the urgency of developing new...
PRAGUE, Czech Republic and BASEL, Switzerland and BOSTON, Mass. –SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SOT109, the company’s potentially best-in-class antibody-drug conjugate (ADC), for the treatment of patients with advanced unresectable or metastatic colorectal cancer (CRC) who have exhausted standard treatment options....
HENDERSON, Nev. – Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations....
SEATTLE, Wash. — Umoja Biopharma, the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma...
SHANGHAI, China & CAMBRIDGE, Mass. — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of extrapulmonary neuroendocrine...
Calgary, Alberta — Zenith Epigenetics Ltd. (“Zenith” or the “Company”) is pleased to announce the designation of ZEN-3694 as a Fast Track product by the U.S. Food and Drug Administration (“FDA”). FDA officials concluded that ZEN-3694, in combination with abemaciclib, meets the criteria for Fast Track designation for the treatment...
THOUSAND OAKS, Calif. –– Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA’s...