Hemlibra was approved to prevent or reduce bleeding in adults and children with hemophilia A without factor VIII inhibitors, a significantly larger patient population than its current indication in patients with factor VIII inhibitors.
An expanded indication for Roche's Hemlibra (emicizumab-kxwh) to prevent or reduce bleeding episodes in adults and children with hemophilia A without factor VIII inhibitors will significantly increase the commercial opportunity for the drug. The Swiss drug maker announced the FDA approval of Hemlibra for routine prophylaxis in the expanded population Oct. 4.
Hemlibra was originally approved in the US for hemophilia A in patients with factor VIII inhibitors in November 2017, but...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
