Latest Fda News

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

4DMedical has secured multi-year agreements to deploy its advanced lung imaging technology across Brazil and Australia, supporting national lung cancer screening programs and enhancing lung health diagnostics.

Botanix Pharmaceuticals’ ECCLOCK® gel, a treatment for excessive sweating, has secured regulatory approval in South Korea, paving the way for a commercial launch in early 2026.

Mesoblast has entered agreements to issue up to US$50 million in convertible notes, aiming to strengthen its capital base and support pipeline growth, pending shareholder approval.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

Amplia Therapeutics has commenced dosing the first patient in its new pancreatic cancer trial combining narmafotinib with FOLFIRINOX chemotherapy, marking a key milestone in its drug development journey.

4DMedical has won a crucial US Medicare reimbursement for its CT, VQ™ lung imaging software, paving the way for rapid adoption across American hospitals. This milestone follows FDA clearance and promises to transform lung diagnostics with safer, faster scans.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

4DMedical Limited has secured FDA clearance for CT – VQ™, the first non-contrast CT-based ventilation-perfusion imaging technology, promising to transform lung diagnostics by replacing traditional nuclear scans.