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 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News FDA takes steps to limit non-human primate testing New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.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 Bayer aims Mirena at women's health issue with no treatment Bayer has started a phase 3 trial of its Mirena contraceptive in an endometrial disorder, with no treatments, that can lead to cancer.
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 Slow recruitment still hitting UK trials, says pharma Despite efforts to improve the environment for UK clinical trials, the sector is still facing headwinds like low recruitment rates and rising costs.
News Merck rare tumour drug Ezmekly backed for NHS use Merck's drug for tumours associated with rare disease neurofibromatosis type 1, Ezmekly, has been cleared for NHS use in children as young as two.
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