ema

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CHMP minded to turn down Alzheimer's drug Aduhelm, says Biog...

Biogen and Eisai have said that the EMA's human medicines committee looks unlikely recommended approval of their Alzheimer's drug Aduhelm when it comes up for discussion next month.

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EMA starts review of Enhertu for HER2+ gastric cancer

The EMA has started its review of AstraZeneca and Daiichi Sankyo's Enhertu for a second indication, as a second-line treatment for HER2-positive gastric cancer.

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EU starts review of Merck's oral COVID drug molnupiravir

The EMA has started a rolling review of Merck & Co and Ridgeback Biotherapeutics' much-anticipated oral antiviral molnupiravir as a treatment for COVID-19 in adults.

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Targeting COVID-19 and cancer with immunotherapy advancements

EU backs broader use of Comirnaty as COVID booster than US

The EMA has given the go-ahead to the use of Pfizer and BioNTech's COVID-19 vaccine Comirnaty as a booster for all people aged 18 or more, but says EU member states must decide for themselv

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EMA looks at booster data for Pfizer/BioNTech COVID-19 jab

The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first co

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