martedì, 5 maggio 2026

Notizie Newsletter

FDA Updates Gilteritinib AML Label With OS Data

May 30, 2019 - The FDA approved a supplemental new drug application (sNDA) to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage ...
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EMA Accepts Application for Trastuzumab Biosimilar

May 29, 2019 - The European Medicines Agency (EMA) has validated and accepted a marketing authorization application for the trastuzumab biosimilar HD201, according to the developer Prestige BioPharma. The application is based on findings from a phase I study and the phase ...
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Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study

Pulmonary embolism is incidentally diagnosed in up to 5% of patients with cancer on routine imaging scans. The clinical relevance and optimal therapy for incidental pulmonary embolism, particularly distal clots, is unclear. The aim of the current study was to assess current ...
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Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

The US Food and Drug Administration’s (FDA’s) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to predict a real clinical ...
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27 maggio 2019 – FDA approva il primo anticoagulante per tromboembolismo venoso sintomatico nei pazienti pediatrici

28 maggio 2019 – Nota Informativa Importante su Tofacitinib (Pfizer)

28 maggio 2019 – Carenza Tolvaptan (Otsuka) – modalità di richiesta d’Importazione dall’estero

28 maggio 2019 – Attivazione Registro Nivolumab (Bristol-Myers Squibb) (cHL)

28 maggio 2019 – Attivazione Registro Venetoclax (AbbVie)

28 maggio 2019 – Attivazione Registro Regorafenib (Bayer) (HCC)