Latest Pharmaceutical Approvals News

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

CSL has secured FDA approval for ANDEMBRY®, a pioneering treatment for hereditary angioedema, enabling an immediate US launch with promising clinical results. This milestone marks a significant advance in managing a rare but debilitating condition.