Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1drop, Agilent, Edwards, Everlywell, Fulgent Genetics, Zebra Medical Vision.
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Akebia, Astrazeneca, Biosig, BMS, Carsgen, Cyclo, Cytodyn, Daiichi, Genentech, Lidds, Nantkwest, Sellas, Teva, Vistagen.
Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date.