regulatory approval

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AstraZeneca and Ionis add an EU green light to earlier approvals in the US and UK for ATTR polyneuropathy drug Wainzua, a potential blockbuster.

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Neurotech Pharma's cell therapy Encelto has become the first FDA-approved therapy for idiopathic macular telangiectasia type 2.

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Genentech has won FDA approval for its clot-buster TNKase as a treatment for acute ischaemic stroke, after almost abandoning the project in 2023.

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Mirum Pharma's Ctexli has become the first FDA-approved therapy for ultra-rare disease cerebrotendinous xanthomatosis (CTX).

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Shionogi will market the EndeavorRide app, originally licensed from Akili, in Japan following its approval by the MHLW regulator.

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Sanofi has claimed FDA approval for the first biosimilar of Novo Nordisk's rapid-acting insulin analogue Novolog.