FDA says it will review an Agios sNDA for a new Pyrukynd indication and sets a 9/7 PDUFA action date.
FDA grants fast track designation to Marengos invikafusp T cell activator for some colorectal cancers.
FDA clears a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement.
Federal Register notice: FDA announces it has issued a priority review voucher to Neurocrine Biosciences because its 12/13 NDA approval for Crenessity...
Fresenius Kabi recalls its Ivenix Infusion System due to potential pneumatic valve failures that may cause the pump to stop an active infusion.
Johnson & Johnson says it is pausing the limited U.S. rollout of its new Varipulse ablation technology while it investigates the root cause of four pa...
FDA grants Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with reduced ejection fr...
Three RebootRx executives call on FDA to create a labeling-only 505(b)(2) NDA pathway to allow non-manufacturers to seek approval for repurposed gener...
