Astellas

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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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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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Astellas strikes $1.7bn SIRP drug deal with Elpiscience

Astellas has struck a deal with fellow Japanese pharma company Elpiscience to develop up to four cancer immunotherapies that work by revving up the activity of macrophages

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FDA starts review of Padcev/Keytruda for bladder cancer

The FDA has kicked off a priority review of a new combination regimen for previously untreated, locally advanced or metastatic urothelial carcinoma (UC), the most common f

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Astellas builds case for menopause drug fezolinetant

New data for Astellas Pharma’s non-hormonal menopause therapy fezolinetant has shown it remains effective to 24 weeks, consolidating the evidence of the drug as it starts

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Xtandi cleared by FDA for earlier-stage prostate cancer

Already a mainstay of prostate cancer therapy, Pfizer and Astellas’ Xtandi has picked up a new approval in the US that could reinvigorate the drug, even as it approaches i

CHMP turns down Neuraxpharm, Apellis drugs

FDA blocks Astellas’ Claudin cancer drug over manufacturing

Astellas strikes $1.7bn SIRP drug deal with Elpiscience

FDA starts review of Padcev/Keytruda for bladder cancer

Astellas builds case for menopause drug fezolinetant

Xtandi cleared by FDA for earlier-stage prostate cancer

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