Latest Fda Review News

Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.

Argenica Therapeutics has dosed 80% of patients in its Phase 2 stroke trial and gained FDA orphan drug designations for its second candidate, ARG-006. The company reports a cash-positive quarter with $15 million in reserves.

Artrya Limited reports solid progress on its FDA 510(k) application and secures a A$5 million capital raise, positioning itself for imminent commercial rollout in the US healthcare sector.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.