The Finnish regulatory agency (FIMEA) has approved Kancera AB’s application to conduct a phase I study of KAND-145, the company’s second-generation fractalkine-blocking candidate drug for cancer.
Endogena Therapeutics Inc. has received FDA clearance of its IND application for EA-2351 for geographic atrophy, an advanced form of age-related macular degeneration (AMD).
Seastar Medical Holding Corp. was granted a third breakthrough device designation by the U.S. FDA for its Selective Cytopheretic device (SCD), a biomimetic membrane-based device used to treat patients with acute inflammatory conditions, which can cause organ failure and death. The latest designation is for its use in patients with hepatorenal syndrome. It follows other indications including cardiorenal syndrome and in adults with acute kidney injury (AKI).
With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond those already established on the country’s two coasts, the Biden administration designated 31 communities, out of more than 370 applicants, as Regional Innovation and Technology Hubs.
The U.S. FDA is once again revising its guidance on how drug and device makers can share scientific reprints and reference texts with health care providers regarding off-label uses of their approved or cleared products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Huizhou Jinghao, Ludica Medical, Medtronic, Vuno.
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.
The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pleural Dynamics.
Vaxcyte Inc. has received FDA clearance of its IND application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease.
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