News Tracy Beth Hoeg will be fifth CDER head this year Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.
News Appeals court turns Enhertu patent dispute on its head A US appeals court has reversed a 2023 decision that ordered Daiichi Sankyo to pay royalties on sales of cancer drug Enhertu to Seagen (now Pfizer).
News AZ uses a priority review voucher for baxdrostat filing Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.
News Pazdur to leave FDA, shortly after taking CDER job Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.
News J&J gets EU approval for Imaavy in gMG J&J's Imaavy has become the first FcRn blocker to be approved in the EU for both adolescent and adult patients with generalised myasthenia gravis.
News FDA doubles down on its push into AI The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.
News MSD gets first FDA okay for oral PCSK9 cholesterol drug MSD has won the race to bring an oral PCSK9 inhibitor through to regulatory approval for LDL cholesterol-lowering in the US.
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