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Approvals, Launches, and New Indications

First Biosimilar For Adults With CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma
First Drug for Rare Autoimmune Disorder That Affects Nerve, Muscles Connection
Hope For Patients With Highly Aggressive Form of AML
Oncology Therapy for Adult and Pediatric Tumors With a Neurotrophic Receptor Tyrosine Kinase (NTRK) Gene Fusion
First Hedgehog Pathway Inhibitor Approved for AML in Adults Aged 75 and Older
First and Only Treatment for Rare Hyper-Inflammation Syndrome With High Mortality
First-Line Treatment for People With Life-Threatening Blood Disorder
First Once-Daily, Nebulized Bronchodilator Available at End of 2018
AI Software Helps Physicians Prioritize Patients with Hemorrhagic Stroke or Intracranial Trauma
Developed for Tumors Resistant to Other TKIs
New Drug Reduces Infection in Chemotherapy Patients
Unique Bio-Identical Hormone Therapy for Treatment of Hot Flashes
Prevents Harmful Effects of Chemotherapy
New Visualization System for Minimally Invasive Spine Surgery
COMPASS Trial Shows 24% Reduction in Major CV Events
Only 18.7% of Patients Treated Had Uveitis Recurrence
Vaccine Prevents Some Cancers, Diseases Caused by 9 HPV Types
First Drug Approved Under Agency’s LPAD Pathway
May Reduce the Need for Open-Heart Surgery
Cleared for Adults with Relapsed or Refractory Disease