The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses
The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China
MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms
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
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