martedì, 5 maggio 2026

Notizie AIOM – anno XVII

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

July 24, 2019 - The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific ...
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CAR T-Cell Therapy MB-102 Granted FDA Orphan Drug Designation for AML

July 24, 2019 - The CAR T-Cell therapy MB-102 has been granted an Orphan Drug Designation by the FDA, according to Mustang Bio, Inc, the manufacturer of the investigational treatment. MB-102, which targets CD123, previously received Orphan Drug status for the treatment of ...
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FDA Grants Priority Review to Tazemetostat for Epithelioid Sarcoma

July 25, 2019 - The FDA has granted a priority review to a new drug application (NDA) for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, according to Epizyme, the manufacturer of the EZH2 ...
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Paediatric Committee elects Koenraad Norga as its new chair

July 24 2019 - At its July 2019 meeting, EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in September. Professor Norga will replace Dr Dirk Mentzer who is retiring as PDCO Chair, having served ...
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Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer

Bevacizumab is an approved treatment after primary debulking surgery for ovarian cancer. However, there is limited information on bevacizumab added to neoadjuvant chemotherapy before interval debulking surgery. To evaluate neoadjuvant bevacizumab in a randomized phase II ...
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22 luglio 2019 – Epatite C: aggiornamento del 22/07/2019 sui pazienti arruolati

23 luglio 2019 – Prossima scadenza presentazione domande Bando AIFA 2018

Statistics Show Increase in US Cancer Survivors

July 22, 2019 - The growth and aging of the population combined with advances in the early detection and treatment of cancer have resulted in a growing population of survivors across the nation, according to a study from the American Cancer Society and the National Cancer ...
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FDA Updates Durvalumab NSCLC Label to Include OS Data

July 22, 2019 - The FDA has updated the label for durvalumab for patients with unresectable, stage III non–small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemoradiation to include overall survival (OS) data from ...
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Neratinib Approved in Canada for Early-Stage HER2+ Breast Cancer

July 17, 2019 - Health Canada has approved neratinib for the extended adjuvant treatment of patients with early-stage, hormone receptor (HR)–positive, HER2-overexpressed/amplified breast cancer within 1 year after completing trastuzumab-based adjuvant therapy. The ...
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