Tag Archive for: FDA

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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Nordic Bioscience receives Letter of Support from the FDA for the PRO-C3 biomarker in tumor fibrosis

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Nordic Bioscience receives Letter of Support from the U.S. Food and Drug Administration (FDA) for further study of the PRO-C3 biomarker assay in tumor fibrosis studies Paves way for further testing of the PRO-C3 biomarker assay, which identifies patients with hard to treat ‘fibrotic’ tumors, in further clinical trials US FDA recognizes need for a […]

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Futura’s Fast-Acting Topical Gel for the Treatment of Erectile Dysfunction Granted Marketing Authorisation by the US FDA for Over the Counter Sale

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Futura Medical plc (AIM: FUM) (“Futura” or the “Company”), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology currently focused on sexual health, today announces that the US Food and Drug Administration (“FDA”) has granted over the counter sale (“OTC”) Marketing Authorisation for MED3000, the Company’s breakthrough, topical gel formulation for the treatment […]

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