Valneva is sticking by its forecast of getting US approval, and getting hold of a lucrative priority review voucher before the end of the year, despite the Food and Drug Administration needing more time to evaluate the French vaccine specialist’s single shot for chikungunya.
Valneva SE is going to have to wait a bit longer to get approval for what could be the world's first vaccine for chikungunya virus after the US Food and Drug Administration pushed back a decision on the jab.
The French group had been given a Prescription Drug User Fee Act (PDUFA) action date for VLA1553 for the end...
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.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
