regulatory approval

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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.

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There are now two vaccines to protect against chikungunya approved for use in the US, after Bavarian Nordic gets the green light for Vimkunya.

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GSK joins arch-rival Pfizer in the market for five-in-one meningococcal vaccines with FDA approval for Penmenvy, a top launch prospect for 2025.