subcutaneous injection

3 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Eisai Co., Ltd. And Biogen Inc.

FDA Extends Review of Eisai-Biogen's LEQEMBI Subcutaneous Formulation to August 2026

FDA extends LEQEMBI IQLIK subcutaneous review to August 2026 without raising approvability concerns, maintaining regulatory momentum for Eisai and Biogen's reformulated Alzheimer's treatment.
BIIBFDA approvalsubcutaneous injection
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Junshi Biosciences Wins NMPA Nod for First Domestic Subcutaneous Anti-PD-1 Drug

Junshi Biosciences wins NMPA approval for JS001sc, first domestic subcutaneous anti-PD-1 drug across 12 indications, delivering clinical parity with IV formulation.
ENGNENGNWPhase 3 clinical trialcancer treatment
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

FDA Accepts Teva's Application for Monthly Olanzapine Injection to Treat Schizophrenia

FDA accepts Teva's application for monthly olanzapine injection treating schizophrenia. The formulation eliminates post-injection monitoring requirements while maintaining efficacy.
TEVAFDA approvalschizophrenia treatment