regulatory

News

The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.

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The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year.

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The FDA said it needs more information before it can approve Regenxbio's gene therapy for Hunter syndrome, in a devastating decision for patients.

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Novo Nordisk's battered stock enjoyed a reprieve after Hims & Hers abandoned plans to launch a compounded version of the new Wegovy pill.

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Amgen confirmed on its fourth-quarter results call that it has resisted a request to pull Tavneos for ANCA-associated vasculitis from the US market.

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FDA has delivered a setback to AstraZeneca by rebuffing its new formulation of lupus therapy Saphnelo, which was approved in Europe last year.