Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”
Bloomsbury Genetic Therapies Ltd. has announced it received orphan drug designations from the FDA and the European Commission for BGT-INAD, an investigational gene therapy for the treatment of infantile neuroaxonal dystrophy (INAD).
Ankyra Therapeutics Inc. has received approval of its IND application by the FDA and its clinical trial application (CTA) by Health Canada for its lead agent, ANK-101, a novel tumor-directed anchored immune medicine.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
The U.S. FDA, Health Canada, and the U.K. Medicines and Healthcare Products Regulatory Agency have once again sidestepped the usual mechanisms for international regulatory cooperation to strike a blow for harmonization.
Kalivir Immunotherapeutics Inc. has announced FDA clearance of an IND application for a phase I study of ASP-1012 (formerly VET2-L2) in participants with locally advanced or metastatic solid tumors. The trial is expected to begin in the first quarter of next year.
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).
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.
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