Lynparza doubled PFS in metastatic patients with germline mutations in BRCA but the FDA usually wants to see OS data before approving drugs for pancreatic cancer. Its advisory committee narrowly voted in favor of approval of the PARP inhibitor but will the agency follow suit?
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee has narrowly voted in favor of supporting approval of AstraZeneca PLC's Lynparza in a subset of pancreatic cancer patients, leaving the agency in bit of a quandary.
ODAC voted 7-5 at a 17 December meeting in favor of Lynparza as a maintenance therapy in patients with germline...
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
