FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage

Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment

This is the first and only subcutaneous immune checkpoint inhibitor available in Europe

Merus and Halozyme collaborate to advance subcutaneous Petosemtamab development

Merus has licensed Halozyme’s proprietary ENHANZE technology to develop and commercialize subcutaneous formulations of petosemtamab

Roche’s subcutaneous lunsumio receives CHMP backing for R/R follicular lymphoma

Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development

The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities

Merck seeks FDA approval for subcutaneous pembrolizumab

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration

OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously

Revolutionary technology will further boost OneSource’s scientific services offerings