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CALQUENCE Granted US Breakthrough Therapy Designation americanpharmaceuticalreview
August 15, 2019AstraZeneca announced the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for CALQUENCE? (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukemia (CLL), one of the most common -
Dynacure Receives Orphan Drug Designation for DYN101 americanpharmaceuticalreview
August 12, 2019Dynacure announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for DYN101, an investigational antisense medicine designed to modulate the expression of dynamin 2 (DNM2) for ... -
APB-102 Receives Orphan Drug Designation for Genetic SOD1 ALS Treatment americanpharmaceuticalreview
July 23, 2019Apic Bio announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).
Pharma Sources Insight July 2025
