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 ...
Drug Store News

Sandoz offers generic Remodulin for subcutaneous administration

Sandoz is offering treprostinil injection for subcutaneous administration to treat patients diagnosed with pulmonary arterial hypertension. Sandoz treprostinil injection was the first generic of ...
The American Journal of Managed Care

FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors

Some experts believe offering a subcutaneous version of nivolumab could make PD-1 inhibitors available to new groups of patients who currently lack access, such as those in rural areas. This article ...
Cure Today

How Subcutaneous vs IV May Affect Treatment Adherence in Cancer Care

The subcutaneous formulation of Opdivo Qvantig reduces administration time to three to five minutes, compared to 30 minutes for the IV version. This formulation offers increased convenience, ...
Nasdaq

Merck Receives Two Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab), for Subcutaneous (SC) Administration and for New Indication for Earlier-Stage Head and Neck Cancer

About Subcutaneous Administration Subcutaneous administration is a method of delivering medications under the skin. As an alternative to intravenous infusion, subcutaneous administration potentially ...
Healio

FDA approves subcutaneous Entyvio as maintenance therapy for ulcerative colitis

Please provide your email address to receive an email when new articles are posted on . The FDA has approved subcutaneous administration of Takeda Pharmaceuticals’ Entyvio for maintenance therapy in ...
Business Wire

FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin ...
Cure Today

Fixed-Dose Subcutaneous Sarclisa Combo is Non-Inferior to IV Sarclisa in R/R Myeloma

Subcutaneous Sarclisa, administered via OBDS, showed non-inferior efficacy to IV Sarclisa in relapsed/refractory multiple myeloma patients. The IRAKLIA study enrolled 532 patients globally, ...
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 ...
The American Journal of Managed Care

Subcutaneous Intrathecal Catheter Allows for Effective Administration of Nusinersen in SMA

A novel indwelling subcutaneous intrathecal catheter circumvented the complex spine anatomy of patients with spinal muscular atrophy (SMA), a challenge when giving nusinersen via intrathecal injection ...
Business Wire

Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration

CHICAGO--(BUSINESS WIRE)--Celltrion USA today announced the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA) for ...