centerforbiosimilars21h
FDA Reviews Golimumab Biosimilar, Samsung Biologics Hits Record Sales, Japan Approves Stelara Biosimilar
The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...
Scholar Rock: More Than Just An SMA Biotech With Q2 2025 Obesity Treatment Data
Scholar Rock submitted its BLA of apitegromab for the treatment of patients with Spinal Muscular Atrophy with a request for ...
AB2 Bio signs U.S. option and licensing agreement with Nippon Shinyaku for Tadekinig alfa for an ultra-rare autoimmune disease
Agreement grants Nippon Shinyaku an option to acquire exclusive U.S. rights to commercialize AB2 Bio’s Tadekinig alfa to treat Primary Monogenic ...
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License ...
TMCnet4d
FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease
INDICATION LEQEMBI ® [ (lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with ...