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Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.

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Ascendis’s growth hormone deficiency drug Skytrofa will offer a convenience advantage as a weekly injectable. But the label does not clearly delineate superiority shown in a Phase III trial.

When FDA Changes Your Payment Plans

Five sponsors withdrew their applications for new technology add-on payments from CMS – all due to regulatory reasons happening at the US FDA.

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