Tag Archive for: FDA clearance

Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687

/in

Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687. This milestone enables Antag […]

Read more

Adcendo Announces US FDA Clearance of IND Application for Phase I/II First-in-Human ADCElerate-01 Trial of ADCE-D01 (uPARAP Receptor Targeting ADC) Trial in Patients with Metastatic and/or Unresectable Soft Tissue Sarcoma (STS)

/in

ADCE-D01 is a first-in-class antibody-drug conjugate (ADC) targeting uPARAP, an endocytic receptor which is highly overexpressed in mesenchymal cancers including multiple STS subtypes The Phase I/II ADCElerate-01 trial is designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS Copenhagen, Denmark, October 8th, 2024 – […]

Read more

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

/in

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 […]

Read more

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

/in

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“), […]

Read more