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The condition has an estimated prevalence of 25,000 patients in the US and an annual incidence of one to three new cases per 100,000 people. CK0804 is an

The company’s plans are expected to increase the capacity for injectable drug products. The expansion, scheduled to commence in early 2026, will add around 300,000ft² of purpose-built space

Sobi will purchase for Arthrosi Skr9.1bn ($950m) in cash. Additional payments of up to Skr5.3bn ($550m) may be made based on clinical, regulatory and sales milestones. The acquisition

The approvals mark the fourth and fifth clearances for the company in the country in 2025. Qfitlia is the antithrombin-lowering therapy indicated for routine prophylaxis in individuals with

Formycon will complete the development of FYB206, prepare and file the regulatory dossier, and supply the biosimilar product. Zydus will manage its commercialisation. FYB206 is nearing the end

Denali’s lead investigational TransportVehicle-enabled enzyme replacement therapy is intended to treat mucopolysaccharidosis type II (Hunter syndrome, a rare genetic disorder affecting boys). The US Food and Drug Administration

The partnership brings together Citizen Health’s AI-based patient insights and advocacy networks with the expertise of UCB in drug development to improve patient outcomes. Under this agreement, Citizen

This submission is the initial application for VIZZ under the exclusive licence and commercialisation agreement signed between LENZ Therapeutics and Lotus in May 2025, and includes South Korea

The company will manufacture the product at its biotechnology facility in Pune, India, which has undergone a previous FDA inspection. Armlupeg is indicated to reduce the risk of