martedì, 5 maggio 2026

Notizie AIOM – anno XVII

EU Panel Recommends Revoking Olaratumab in Soft Tissue Sarcoma

April 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the conditional marketing authorization for olaratumab be revoked following results of the ANNOUNCE study, which did not demonstrate a survival ...
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Talazoparib Approaches EU Approval for BRCA-Mutated, HER2-Negative Breast Cancer

April 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of talazoparib for adult patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA1/2 mutations, according to ...
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Low Rates of Patient-Reported Physician–Patient Discussion about Lung Cancer Screening among Current Smokers: Data from Health Information National Trends Survey

Many professional societies published guidelines recommending lung cancer screening with low-dose CT scan. We examined the temporal trends in patient-reported physician–patient discussions about lung cancer screening, and aimed to determine the association of discussions ...
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29 aprile 2019 – Aggiornamento – Le Autorità Europee lavorano per evitare la carenza di medicinali per effetto di Brexit

29 aprile 2019 – Nota Informativa Importante su Alemtuzumab (Genzyme)

30 aprile 2019 – Comunicazione EMA su Lapatinib (Glaxo)

2 maggio 2019 – Attivazione del Registro Ribociclib (Novartis)

2 maggio 2019 – Nota Informativa Importante sull’uso dei medicinali a base di domperidone

3 maggio 2019 – FDA approva la prima terapia mirata per il carcinoma della vescica metastatico

FDA Grants Priority Review to Darolutamide in Nonmetastatic CRPC

April 29, 2019 - The FDA has granted a priority review designation to a new drug application (NDA) for darolutamide for use as a treatment for patients with nonmetastatic castration-resistant prostate cancer (CRPC). The NDA is based on data from the phase III ARAMIS trial, ...
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