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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

The approval enables the use of inavolisib in patients whose cancer has recurred during or shortly after hormone therapy and has metastasised to other areas of the body.

The approach is consistent with outpatient settings as per US Food and Drug Administration (FDA)-approved use. The initiative enhances access to non-oral diuretic therapy throughout CVL’s cardiovascular practice

Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a