martedì, 5 maggio 2026

Notizie AIOM – anno XVII

FDA Approval Sought for Neratinib Combo in HER2+ Breast Cancer

July 1, 2019 - A supplemental new drug application (sNDA) has been submitted to the FDA for neratinib for use in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed ...
Leggi tutto

FDA Approves Avatrombopag in Chronic ITP

July 1, 2019 - The FDA has approved a supplemental new drug application (sNDA) to expand the use of avatrombopag to include the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy. The approval of ...
Leggi tutto

Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

July 1, 2019 - The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made. We recognize that the choice of which medication ...
Leggi tutto

Cemiplimab Approved in Europe for Cutaneous Squamous Cell Carcinoma

July 1, 2019 - The European Commission approved cemiplimab for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals ...
Leggi tutto

Call for all sponsors to publish clinical trial results in EU database

July 3, 2019 - The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of ...
Leggi tutto

Medicine shortages: EU network takes steps to improve reporting and communication

July 4, 2019 - The European Union task force set up to address problems with medicines supply has published two documents today: guidance for marketing authorisation holders on reporting of shortages in the EU; good practice guidance for communication to the public on medicines’ ...
Leggi tutto

Lung Cancer Incidence and Mortality with Extended Follow-up in the National Lung Screening Trial. National Lung Screening Trial Writing Team 1

The National Lung Screening Trial (NLST) randomized high-risk current and former smokers to 3 annual screens with either low-dose computed tomography (LDCT) or chest radiographs (CXR) and demonstrated a significant reduction in lung cancer mortality in the LDCT arm after ...
Leggi tutto

Treatment Outcomes of Immune-Related Cutaneous Adverse Events

The aim of the current study was to report the efficacy of topical and systemic treatments for immune-related cutaneous adverse events (ircAEs) attributed to checkpoint inhibitors in an uncontrolled cohort of patients referred to oncodermatology clinics. A retrospective ...
Leggi tutto

4 luglio 2019 – Impegnati a risolvere questione carenze ma rassicuriamo i pazienti

EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case with Canary Wharf Group

July 4, 2019 - The European Medicines Agency has reached an agreement with Canary Wharf Ltd over its premises at 30 Churchill Place, London, in accordance with the discussions held with the EU budgetary authorities. EMA announces today that it has sublet all of its 284,704 ...
Leggi tutto