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Eisai and Biogen facing delay to Leqembi in Europe

Around 14 months after Eisai and Biogen’s Leqembi was filed for approval in the EU, the bloc’s regulatory authority has delayed making a decision on the Alzheimer’s drug.

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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

Eisai and Biogen facing delay to Leqembi in Europe

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 seeks input on virtual alternative to animal test

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