FDA clearance gives Maverix Medical a 2027 U.S. launch path for its console-free Narwhal Cryo System, but adoption will hinge on workflow and economics.
PleoPharma secures $6.5M NIDA funding as a 420-patient Phase 3 trial tests PP-01 for cannabis withdrawal in adults with cannabis use disorder.
Shanghai Ark Biopharmaceutical Co., Ltd. ((ArkBio) has received authorization from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 trial of ziresovir, an oral antiviral being developed for infants with severe respiratory syncytial virus infection, including patients requiring treatment in a pediatric intensive care unit. The planned multicenter, randomized, double-blind and placebo-controlled
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
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 allows up to 30 more patients in Signature Biologics’ DMD UC-MSC program, expanding access while efficacy remains unproven.
Adaptyx and Attune begin a $4 million ARPA-H-backed study testing continuous biomarkers and focused ultrasound in 100 adults with chronic pain.
Quantum BioPharma Ltd. (NASDAQ: QNTM) said on August 10, 2026 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug programme for Lucid-MS, also known as Lucid-21-302, allowing the company to proceed with a randomized, double-blind, placebo-controlled Phase 2 study in progressive multiple sclerosis. The regulatory decision permits clinical development to
GRAIL, Inc. will face a potentially defining regulatory examination on September 23, 2026, when outside advisers to the United States Food and Drug Administration review the premarket approval application for its Galleri multi-cancer early detection blood test. The FDA’s Molecular and Clinical Genetics Panel is scheduled to discuss and vote on whether the available evidence
Kardium wins Health Canada approval for the Globe Pulsed Field System, extending its integrated atrial fibrillation platform beyond the U.S.