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CHMP calls in advisors to assist in Leqembi review

Eisai and Biogen’s marketing application for Alzheimer’s disease therapy Leqembi will face an independent advisory committee convened by the EMA before a decision is made

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EMA finds no evidence GLP-1 agonists cause thyroid cancer

The EMA’s safety committee has said that, after a review of available data, it has found no evidence that GLP-1 agonist drugs such as Novo Nordisk’s Ozempic and Eli Lilly’

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Ipsen to refile Alagille drug after EU blocks orphan status

Ipsen has said that it plans to file a new marketing application for its treatment for itch in Alagille syndrome (ALGS), Bylvay, after failing to persuade an EMA committee

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EU clears review of Xtandi in earlier-stage prostate cancer

The EMA will kick off a review of Astellas and Pfizer's prostate cancer therapy Xtandi in an earlier-stage form of the cancer, which if approved could give the product a l

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EMA backs SV95C as digital primary endpoint for DMD trials

The EMA has endorsed a digital measurement using wearables developed by Sysnav Healthcare as a primary endpoint for use in trials involving patients with Duchenne muscular

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EMA probes suicide risk with Novo Nordisk obesity drugs

The European Medicines Agency (EMA) has started a review of two Novo Nordisk drugs used to treat obesity and those overweight, following reports of suicidal thoughts or se

CHMP calls in advisors to assist in Leqembi review

EMA finds no evidence GLP-1 agonists cause thyroid cancer

Ipsen to refile Alagille drug after EU blocks orphan status

EU clears review of Xtandi in earlier-stage prostate cancer

EMA backs SV95C as digital primary endpoint for DMD trials

EMA probes suicide risk with Novo Nordisk obesity drugs

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

Discover a new era of healthcare panel engagement: Grounded ...

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