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 ...
Business Wire3d
Scholar Rock Submits Biologics License Application (BLA) to the U.S. FDA for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA)
today announced the submission of a Biologics License Application to the U.S. Food and Drug Administration (FDA) for apitegromab, a muscle-targeted therapy designed and developed to provide ...
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: 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 ...
GlobalData on MSN4d
AB2 Bio and Nippon Shinyaku enter Tadekinig alfa licensing deal
AB2 Bio has made an option and licencing agreement with Nippon Shinyaku, granting the latter the option to obtain exclusive ...
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 ...
Monthly Prescribing Reference5d
Leqembi Monthly IV Maintenance Dosing Approved for Early Alzheimer Disease
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
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 ...
Nasdaq5d
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 ...