Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: SUNSET rule suspended; Alliance calls for speedy nomination of FDA commissioner; Pandemic costly to TB effort; FDA announces May 4 patient data meeting.
Barely five and a half years since the company was founded, Kiniksa Pharmaceuticals Ltd. has moved its first drug over the finish line, winning FDA approval for interleukin-1 blocker (IL-1) rilonacept to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 and older.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Idorsia, J&J, Kiniksa, RDIF.
Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia.