Sponsor's proposal for a label warning, but not a black box, on retinopathy risk with the once-weekly GLP-1 agonist finds support from a US FDA advisory committee, which overwhelming endorsed approval for treatment of type 2 diabetes on the basis of robust glycemic control efficacy data and a strong cardiovascular safety profile.
A US FDA panel's recommendation for a retinopathy label warning on Novo Nordisk AS' semaglutide seems unlikely to dim the GLP-1 receptor agonist's commercial prospects given its robust glycemic control effects and reassuring cardiovascular safety profile.
At an Oct. 18 meeting, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0, with one abstention, that the efficacy...
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.
As clinical trials grow more complex, execution pressures are changing where and how evidence is collected.
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.
