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New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.

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Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.

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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.

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Despite efforts to improve the environment for UK clinical trials, the sector is still facing headwinds like low recruitment rates and rising costs.

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The EMA has started a review of a regimen based on Pfizer/Astellas' Padcev and MSD's Keytruda that is described as a game-changer for bladder cancer.