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

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion

Developing basic technology for personalized medicine: Dr. Paidi Yella Reddy, Founder & CEO, Sapala Organics

Developing basic technology for personalized medicine: Dr. Paidi Yella Reddy, Sapala Organics

Bristol Myers Squibb, Johnson & Johnson halt major heart-drug trial after disappointing results

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases

AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo

Sun Pharma discontinue development of SCD-044 drug after trial disappointment

Sun Pharma discontinues work on its experimental skin drug SCD-044 after Phase 2 trial results fall short of goals for treating psoriasis and atopic dermatitis

Wanbury to implement the SAP S/4 HANA private cloud platform

The implementation, spearheaded by Deloitte Consulting, brings together domain expertise and cutting-edge technology