BOSTON, Mass. — EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for cladribine capsules for the treatment of the rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia Gravis (gMG). In...
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SHANGHAI, China — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous...
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...
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...
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...
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 prior...
SAN DIEGO, Calif. and TOYKO, Japan — Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTI™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible...
Ridgefield, Conn. — Boehringer Ingelheim today announced HERNEXEOS® (zongertinib tablets) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. “Exploring accelerated...