REDWOOD CITY, Calif. — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to elironrasib, the company’s RAS(ON) G12C-selective inhibitor, for the treatment of adult patients...
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GAINESVILLE, Fla. — Neuropacs™ Corp., an innovator in AI-enabled neurological imaging, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification to neuropacs™, a diffusion MRI–based software application designed to assist clinicians in the evaluation of Parkinsonian syndromes. neuropacs™ is the first medical device classified...
TAIPEI, Taiwan — AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, the first-in-class for therapy for spinal and bulbar muscular atrophy (SBMA, also known as Kennedy’s disease). “Receiving the Fast Track Designation for AJ201 marks a...
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...
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...
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)...
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...