Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion
Patient enrolment has been completed in Cynata's Phase 2 clinical trial of CYP-001 in acute graft versus host disease
Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
Vamikibart is the first targeted, non-steroid treatment designed to address the underlying inflammation driving UME
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