Fierce Pharma

FDA rejects AZ's subQ Saphnelo, but company expects quick turnaround for new approval decision

AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version of lupus treatment Saphnelo. | AstraZeneca will have to negotiate what ...
Nasdaq

Eisai: Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Approved in Japan

TOKYO, Feb 16, 2024 - (JCN Newswire) - - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced that they have obtained ...
Nasdaq

Viridian Therapeutics Enters Autoinjector Pen Device Customization and Supply Agreement with Ypsomed AG for Subcutaneous Drug Delivery in Thyroid Eye Disease

- Supply agreement supports Viridian’s development of potential first- and best-in-class subcutaneous therapies for treatment of thyroid eye disease (TED) - - Ypsomed brings strong track record of ...
Business Wire

Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions

– Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks – – Ocrevus subcutaneous injection was ...
Pharmabiz

AstraZeneca’s Saphnelo approved in EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union (EU) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on ...
Healio

FDA accepts BLA for Leqembi subcutaneous autoinjector maintenance dosing

Please provide your email address to receive an email when new articles are posted on . The FDA has accepted Eisai and Biogen’s biologics license application for a subcutaneous autoinjector weekly ...
ascopubs.org

Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary ...

Five-Year Follow-Up of Standard-of-Care Axicabtagene Ciloleucel for Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium Subcutaneous amivantamab-lazertinib demonstrated noninferior ...
Business Wire

Viridian Therapeutics Enters Autoinjector Pen Device Customization and Supply Agreement with Ypsomed AG for Subcutaneous Drug Delivery in Thyroid Eye Disease

WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare ...