Neurology Advisor

Subcutaneous Lecanemab Starting Dose Under Review for Alzheimer Disease

The FDA has accepted for review the sBLA for subcutaneous lecanemab-irmb as a weekly starting dose for Alzheimer disease.

FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s

Eisai and Biogen have announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental ...
Oncology Nurse Advisor

FDA Approves Subcutaneous Rybrevant Faspro for EGFR-Mutated Non-Small Cell Lung Cancer

Subcutaneous administration takes less time and is tied to fewer administration-related reactions than intravenous.

Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting ...

FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...
Seeking Alpha

European Commission Approves Subcutaneous Administration of KEYTRUDA® (pembrolizumab) for All Adult Indications Approved in the European Union

This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute “We are honored to ...
PMLive

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Eisai and Biogen’s Supplemental Biologics License Application (sBLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) has been accepted by the US FDA under Priority Review to treat early ...
Contract Pharma

Datwyler Launches Industry-First Large-Volume Plunger

Datwyler says it has developed a first-to-market universal plunger for large-volume cartridges containing up to 20mL.
Rutland Herald

KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and ...