Tag Archive for: FDA clearance

iOnctura announces FDA clearance of IND application for roginolisib, a first-in-class allosteric modulator of PI3Kδ

Roginolisib is in development for solid and hematologic malignancies including uveal melanoma Geneva, Switzerland and Amsterdam, The Netherlands, 31 October 2023 – iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, today announces that the US Food and Drug Administration (FDA) has granted permission to proceed […]

Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure

MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart failure therapy Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), […]