Tag Archive for: FDA

US FDA grants Orphan Drug Designation for iOnctura’s first-in-class autotaxin cancer therapy

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Autotaxin inhibitor, IOA-289, recently received the proposed INN cambritaxestat Cambritaxestat is in the Phase I AION-02 trial in combination with chemotherapy in metastatic pancreatic cancer It is the first autotaxin inhibitor to be investigated in cancer patients Amsterdam, The Netherlands and Geneva, Switzerland, 7 March 2024 – iOnctura, a pioneering, clinical-stage biotechnology company developing transformative cancer […]

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Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2

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RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion It is the first product based on RENOVITE®, Renovos’ novel nanoclay therapeutic delivery platform for precision regenerative medicine Keele, UK, 4 January 2024 – Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating […]

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Versameb Announces FDA Clearance of IND Application for VMB-100 in the Treatment of Stress Urinary Incontinence

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Versameb AG (“Versameb”), a pre-clinical stage company focused on transforming RNA therapeutics to treat unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application of VMB-100, a potency enhanced messenger ribonucleic acid (mRNA) encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress […]

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Verona Pharma: Preparing a potentially novel COPD medicine for market

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A much-anticipated new potential drug for COPD moved a step closer to the market after Verona Pharma submitted its New Drug Application  to the U.S. FDA, seeking approval of ensifentrine as a maintenance therapy. In the latest episode of Optimum Perspectives podcast, Eva Haas caught up with Chris Martin, Senior Vice President of Commercial, who […]

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Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO®

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Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) seeking full approval of TARPEYO® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. TARPEYO is currently approved under accelerated approval to reduce […]

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