Tag Archive for: FDA

U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy

225Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma Orphan Drug Designation follows outstanding preclinical data and FDA IND clearance Phase I/II human trials set to commence in Q1 2025 as a ‘theranostic’ targeted radionuclide treatment Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a […]

Alys Pharmaceuticals receives IND clearance for Phase 2a trial of first genetic medicine program in dermatology

ALY-101 is an intradermal injectable JAK1 siRNA-lipid conjugate for the treatment of Alopecia Areata Significant progress made in advancing the Alys pipeline following $100m seed financing from Medicxi Boston, Massachusetts and Lausanne, Switzerland, 4th February 2025 – Alys Pharmaceuticals, Inc. (“Alys”), an immune-dermatology focused company, today announces that the U.S. Food and Drug Administration (FDA) […]

Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

SpliceBio Announces U.S. FDA IND Clearance of SB-007 to Commence Phase 1/2 Clinical Study in Patients with Stargardt Disease

SB-007 is the only IND-cleared, clinical-stage therapeutic addressing the root cause of Stargardt disease with the potential to treat all patients across all ABCA4 mutations Phase 1/2 ASTRA study set to begin in the first half of 2025, supported by POLARIS, a pioneering company-sponsored natural history study in Stargardt disease First ever IND clearance for […]

BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations

Paris, France – November 18th, 2024 – BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA  510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the fetal heart. This milestone marks a significant breakthrough in one of the most challenging and critical […]