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News about "US FDA Breakthrough Therapy Designation"
US FDA Grants Breakthrough Therapy Designation to Calderasib for KRAS G12C-Mutant NSCLC
Calderasib has received US FDA Breakthrough Therapy Designation for certain patients with newly diagnosed metastatic KRAS G12C-mutant Non-Small Cell Lung Cancer (NSCLC), supported by promising phase 1 KANDLELIT-001 trial data highlighting its potential as a next-generation, highly potent and selective KRAS G12C inhibitor.
US FDA Breakthrough Therapy Designation | 30/05/2026 | By News Bureau | 108
Emiltatug Ledadotin Wins FDA Breakthrough Tag for Adenoid Cystic Carcinoma
Emiltatug Ledadotin receives U.S. Food and Drug Administration Breakthrough Therapy designation for adenoid cystic carcinoma, a potentially innovative and differentiated Antibody Drug Conjugate (ADC) directed against B7-H4, a well-characterised target in certain cancers including ACC.
US FDA Breakthrough Therapy Designation | 13/05/2026 | By News Bureau | 135
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