Pharm Exec3d
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...
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 ...
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 ...
JD Supra1d
Alvotech and Teva Announce Acceptance of BLA for AVT05, a Golimumab Biosimilar
Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar ...
BioArctic: FDA approves IV maintenance dosing of Leqembi (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's ...
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 ...
Alvotech: FDA To Review BLA For AVT05 - Quick Facts
Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has ...
The American Journal of Managed Care1d
How FcRn Blockade Targets Myasthenia Gravis Autoantibodies
In part 2 of our interview with Katie Abouzahr, MD, Johnson & Johnson Innovative Medicine, we discuss the challenge inherent ...
Nasdaq4d
Alvotech: FDA To Review BLA For AVT05 - Quick Facts
(RTTNews) - Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has accepted for review Biologics License Applications ...
Zacks.com on MSN2d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...