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AU’s TGA grants orphan drug designation to Roche’s glofitamab

Apr 21, 2022

Australia’s TGA granted orphan drug designation to Roche’s glofitamab.  The TGA also provided approval for Roche to apply for registration using the provisional approval pathway, an expedited approval process.  Roche has until 21 October 2022 to make an application through this pathway.

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