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 ...
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 ...
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 ...
centerforbiosimilars17h
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 ...
Contract Pharma3d
FDA Accepts Alvotech’s Biosimilar to Simponi (Golimumab) for Review
The U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Macau Business3d
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 ...
clinicaladvisor.com2d
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.
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 ...