ema

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Concerns about efficacy data in the main trial behind the approvals of Amgen and CSL Vifor's Tavneos have triggered a review in the EU.

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EMA starts its review of first-line Enhertu in HER2+ breast cancer, which could dramatically increase the eligible patient population for the drug.

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The FDA and EMA have come up with guiding principles that they say will underpin future guidance on the use of AI technologies in drug development.

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Agreement has been reached on the reform of EU pharma legislation, but industry thinks it does not go far enough to restore the bloc's global status.

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Sanofi is celebrating an approval recommendation in the EU for Teizeild, a first-in-class drug designed to delay the progression of type 1 diabetes.

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Eli Lilly's appeal of a decision by the EMA's human medicines committee not to approve its Alzheimer's disease therapy Kisunla has paid off.