R&D News | pharmaphorum

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Bayer has started a phase 2a trial of an antibody that it hopes could provide a targeted, potentially disease-modifying therapy for Alport syndrome.

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Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.

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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.

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New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.

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Bayer has started a phase 3 trial of its Mirena contraceptive in an endometrial disorder, with no treatments, that can lead to cancer.

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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.