The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Vesalio for pVasc NET, a peripheral mechanical thrombectomy device that combines a self-expanding clot retriever with a fine-pore, dual-layer filter positioned at its distal end. The FDA classified the device as substantially equivalent through the Special 510(k) pathway on August 5, 2026. Vesalio
Capricor Therapeutics says the United States Food and Drug Administration (FDA) is willing to review an amendment containing 24-month HOPE-3 data for deramiocel, keeping the experimental Duchenne muscular dystrophy cell therapy under active consideration despite a strongly negative advisory committee vote. The company intends to narrow the regulatory case from Duchenne-associated cardiomyopathy to preservation of
Samsung Electronics has received United States Food and Drug Administration (FDA) clearance for software that allows compatible Galaxy Buds to function as self-fitting, over-the-counter hearing aids for adults with perceived mild to moderate hearing impairment. The Hearing Aid Feature will initially be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States
Bristol Myers Squibb has secured accelerated approval from the United States Food and Drug Administration for Zenbexus, making iberdomide the first therapy from the company’s CELMoD class to reach the US market. The oral drug was approved as part of a three-drug regimen with subcutaneous daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma
Actinium advances Actimab-A IP and manufacturing while NYSE American compliance adds a parallel financing and execution test.
Fannin secured new grants to advance an IL1RAP-targeted RapDC for Ewing sarcoma, moving its synthetic drug-conjugate platform toward proof of concept.
FDA’s Class II proposal could lower a major equipment barrier for Photocure’s Cysview. See what the regulatory shift could mean for US adoption.
FDA approves Lantheus’ Tauklarify for Alzheimer’s tau PET imaging. See what the scan detects, where errors arise and what could limit access.
Veloxis Pharmaceuticals will pay over $46 million over Envarsus XR conduct. See why five years of compliance oversight could matter even more.
Aizen Therapeutics lands an oral peptide collaboration with several million dollars upfront and up to $100 million in milestones per target.