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FDA Issues Complete Response Letter to Novo Nordisk for Icodec, a Once-Weekly Basal Insulin for the Treatment of Diabetes Mellitus
FDA Issues Complete Response Letter to Novo Nordisk for Icodec, a Once-Weekly Basal Insulin for the Treatment of Diabetes Mellitus

July 11th 2024

According to the Complete Response Letter, the FDA has requested additional information on the manufacturing process and the type 1 diabetes indication for insulin icodec before completing its review.

FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis
FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis

July 10th 2024

FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures
FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures

July 9th 2024

FDA Grants Full Approval to Johnson & Johnson’s Sirturo for Pulmonary Tuberculosis Caused by Mycobacterium Tuberculosis Resistant to Rifampicin and Isoniazid
FDA Grants Full Approval to Johnson & Johnson’s Sirturo for Pulmonary Tuberculosis Caused by Mycobacterium Tuberculosis Resistant to Rifampicin and Isoniazid

July 8th 2024

FDA Approves Genentech’s Vabysmo Prefilled Syringe to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Macular Edema Following Retinal Vein Occlusion
FDA Approves Genentech’s Vabysmo Prefilled Syringe to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Macular Edema Following Retinal Vein Occlusion

July 8th 2024

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