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 FDA clears trial of 'vectorised' ALS antibody from VectorY VectorY has been cleared by the FDA to start human trials of a drug against a target implicated in up to 97% of amyotrophic lateral sclerosis cases.
News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.
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 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 EU clears first drug therapy for rare disease cALD Neuraxpharm and Minoryx' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cALD.
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