The designation, which covers serious and life-threatening diseases affecting those under 18, may allow the company a paediatric priority review voucher for future regulatory submissions. SGT-212 is designed
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 formulation will serve as a new administration route. Eisai’s application is based on data from several SC administration sub-studies of lecanemab, conducted within the Phase III Clarity
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 therapy is intended for patients who have undergone at least three previous therapies, including an immunomodulatory agent and a proteasome inhibitor. The approval is the first authorisation
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 decision is intended for those who have previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label,
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
The deal sets the vaccine price at $2.99 per dose and is expected to take effect within a year, supporting Gavi’s goal to fully vaccinate 50 million more
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
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