Pharm Exec4d
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 ...
JD Supra2d
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 ...
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 ...
PharmaTimes3d
Cartesian Therapeutics announces FDA agreement for new trial
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...
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 ...
The American Journal of Managed Care2d
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 ...
GlobalData on MSN4d
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...
Cure Today6d
Opdivo Plus Yervoy May Improve Survival and Responses in Frontline uHCC
Opdivo plus Yervoy shows efficacy and manageable safety as first-line treatment for unresectable hepatocellular carcinoma in ...
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 ...