Notizie AIOM – anno XV
Japanese Approval Sought for Frontline Osimertinib in NSCLC
November 27, 2017 - A supplemental new drug application (sNDA) has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the use of osimertinib as a frontline treatment for patients with inoperable or recurrent EGFR-positive non–small cell ...Leggi tutto
ASCO Applauds New Report on Making Medicines Affordable
November 30, 2017 - Today, ASCO President Bruce E. Johnson, MD, FASCO, released the following statement: “A report released today by the National Academies of Sciences, Engineering, and Medicine underscores the imperative our nation faces to address the affordability ...Leggi tutto
FDA Grants Mogamulizumab Priority Review for CTCL
November 28, 2017 - The FDA has granted a priority review to a biologics license application (BLA) for mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy, according to Kyowa Hakko Kirin, the ...Leggi tutto