The filing is backed by results from the pivotal SERENA-6 Phase III trial
First-in-human study of investigational SOS1 inhibitor shows encouraging safety profile and early anti-tumor activity in patients with metastatic solid tumors
Libre Duo devices become the first glucose-ketone monitors approved for diabetes care, offering real-time alerts for diabetic ketoacidosis risk
From import dependence to global leadership, the next phase of growth must be driven not only by manufacturing scale and policy support, but also by innovation, research, and globally competitive healthcare technologies
The move marks one of the most significant coverage expansions yet in obesity care, bringing FDA-approved treatment options further into mainstream insurance plans rather than out-of-pocket reach
BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes
The company is set to unveil new clinical data across obesity, diabetes, kidney, and liver disease programs
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
These data support clinically meaningful efficacy within this patient population. We observed a high rate of complete responses in patients with laCSCC
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