Nasdaq

Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types

Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

Saphnelo® subcutaneous approved in Canada for the treatment of systemic lupus erythematosus

CNW/ - Health Canada has granted a Notice of Compliance (NOC) for Saphnelo® (anifrolumab injection) for subcutaneous self-administration via a ...
Nasdaq

Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis

OCREVUS subcutaneous (SC) injection offers a new, 10-minute administration of OCREVUS with comparable efficacy and safety to intravenous infusion (IV) OCREVUS SC provides an additional treatment ...
Targeted Oncology

IRAKLIA Trial Validates Subcutaneous Isatuximab in Multiple Myeloma

Sikander Ailawadhi, MD, of the Mayo Clinic Florida in Jacksonville, discusses the clinical significance and primary outcomes ...
Benzinga.com

Back-To-Back FDA Approvals For Roche's Two Under-The-Skin Injections

Ocrevus Zunovo is the first and only biannual professional-administered ~10 min SC injection approved for both forms of multiple sclerosis. The subcutaneous formulation of Tecentriq received its first ...
The American Journal of Managed Care

First Subcutaneous Prophylaxis for Hemophilia A and B With Inhibitors Approved by FDA

Concizumab-mtci (Alhemo) is approved for hemophilia A or B with inhibitors, offering a subcutaneous alternative to intravenous treatments. The phase 3 explorer7 trial demonstrated an 86% reduction in ...
MPR

Subcutaneous Teprotumumab Meets Phase 3 Endpoints in Active TED

The TEPEZZA OBI trial evaluated the safety and efficacy of SC teprotumumab in patients with active TED and proptosis of 3mm or greater from baseline.
ascopubs.org

Subcutaneous Immunotherapy in Cancer: Where We Are Now, What It Changes, and What to Watch Next

Subcutaneous (SC) formulations of monoclonal antibodies are rapidly transforming the delivery of cancer immunotherapy. Designed to replace or complement intravenous (IV) administration, SC delivery ...
Business Wire

Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory ...

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration ...