Pharm Exec1d
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 ...
Healio13d
FDA grants biologics license application for monthly IV Leqembi
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
PDUFA action date of July 22, 2025, with priority reviewWOBURN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the ...
Morningstar7d
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The FDA granted the BLA Priority Review ...
Macau Business1d
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to...
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva ...
FDA Accepts LEQEMBI (Lecanemab-Irmb) Biologics License Application For Subcutaneous Maintenance Dosing For The Treatment Of Early Alzheimer's Disease
( MENAFN - JCN NewsWire) FDA Accepts LEQEMBI (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the treatment of Early Alzheimer's disease LEQEMBI is the only ...
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 ...