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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 ...
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Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...
FDA accepts Teva, Alvotech BLAs for Simponi biosimilars
The FDA has accepted Alvotech (ALVO) and Teva's (TEVA) applications for AVT05, their proposed biosimilar to J&J's ...
Alvotech, Teva announce FDA accepts BLA for AVT05
Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the U.S. FDA has ...
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 ...