regulatory

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CHMP turns down Neuraxpharm, Apellis drugs

The EMA’s human medicines committee refused marketing approvals for two drugs from Neuraxpharm and Apellis at its January meeting, but both companies have said they will a

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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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FDA blocks Astellas’ Claudin cancer drug over manufacturing

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug can

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Click bags FDA breakthrough tag for schizophrenia DTx

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia

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MHRA’s post-Brexit mutual recognition framework goes live

The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the U

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