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NewStem Files FDA Pre-Submission and EMA IVDD for Revolutionary Life-Saving, Treatment-Changing Diagnostic Device

Bio-Platform NewStem Ltd announced the filing of a pre-submission to the FDA for a De Novo Request and an in vitro diagnostic device (IVDD)...

Debiopharm Announces Oncology Research Advancements at AACR 2022 for Novel Cancer Compounds and Drug Delivery Technologies

Debiopharm, an oncology and infectious disease focused biopharmaceutical company based in Switzerland, today announced data releases on 3 investigational products including Debio 0123 (Selective...

Israeli Startup Sanolla Receives FDA Clearance for the World’s First AI-Ready Infrasound Stethoscope

Israeli startup Sanolla, which provides AI-powered primary care diagnostic solutions, announced that the FDA has granted 510(k) clearance for the clinical use of the...

Kuleana Technology Receives the NKF Innovation Fund’s First Dialysis Investment

Kuleana Technology, Inc. (Kuleana), a Seattle Washington-based company, received the National Kidney Foundation (NKF) Innovation Fund's first dialysis investment. Kuleana is developing a groundbreaking...

Aeglea BioTherapeutics Presents Additional Data from PEACE Phase 3 Study of Pegzilarginase for the Treatment of Arginase 1 Deficiency at SIMD

Aeglea BioTherapeutics, Inc., a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, shared additional...
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