Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
You may also be interested in...
Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.
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had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
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.