lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

Regulatory information – adjusted fees for applications to EMA from 1 April 2019

March 1, 2019 - The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2019. Every year, the European Commission adopts ...
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New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

March 1, 2019 - EMA’s human medicines committee (CHMP) has adopted a positive opinion for sotagliflozin intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus. Sotagliflozin is a small molecule with dual inhibitor activity on SGLT1 and ...
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EU Panel Backs Lorlatinib for ALK+ NSCLC

March 1, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of lorlatinib for the treatment of adult patients with ALK-positive advanced non–small cell lung cancer (NSCLC) whose disease has progressed ...
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EU Panel Backs Olaparib for BRCA-Mutant Advanced Breast Cancer

March 1, 2019 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to olaparib tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic ...
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FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

February 25, 2019 - The U.S. Food and Drug Administration has issued a warning letter to Total Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole ...
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FDA Grants Lenalidomide/Rituximab Priority Review for Indolent Non-Hodgkin Lymphoma

February 26, 2019 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the R2 regimen of lenalidomide plus rituximab for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL). The sNDA ...
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FDA Panel Votes Against Accelerated Approval of Selinexor for Myeloma

February 26, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 against accelerated approval of a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on ...
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FDA Approval Sought for Darolutamide for Nonmetastatic CRPC

February 27, 2019 - A new drug application (NDA) has been filed with the FDA for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to the codevelopers of the investigational agent, Bayer and Orion Corporation. ...
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FDA Approves Subcutaneous Trastuzumab Formulation for HER2+ Breast Cancer

February 28, 2019 - The FDA has approved subcutaneous use of trastuzumab and hyaluronidase-oysk injection in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic ...
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FDA Approves Aprepitant Injection for CINV

February 28, 2019 - The FDA has expanded the approval of aprepitant injectable emulsion to include a 2-minute intravenous (IV) use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). The decision is based on results of a two-part, phase ...
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