lunedì, 4 maggio 2026

Notizie Newsletter

The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature

It is unclear whether patients with advanced cancer value surrogate end points, particularly progression-free survival (PFS). Despite this uncertainty, surrogate end points form the basis of regulatory approval for the majority of new cancer treatments. To summarize and ...
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1 ottobre 2019 – Registri AIFA: informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C

2 ottobre 2019 – AIFA: vaccini influenzali per la stagione 2019-2020

3 ottobre 2019 – Nota Informativa Importante su Ondansetron

FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

Oct 1, 2019 - Today, the U.S. Food and Drug Administration is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by ...
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NCCN Grants Category 1 Recommendation to Pexidartinib for TGCT

Sep 26, 2019 - The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Soft Tissue Sarcoma to include a category 1 recommendation for pexidartinib for the treatment of patients with tenosynovial giant cell tumor (TGCT). ...
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FDA Approves CRC Screening Test for Younger, At-Risk Individuals

Sep 23, 2019 - The FDA has expanded the approval of the noninvasive colorectal cancer (CRC) screening test Cologuard to include eligible at-risk individuals ≥45 years. The updated indication of the at-home stool-based screening assay applies to approximately 19 million ...
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FDA Approves Frontline Daratumumab Regimen for Transplant-Eligible Myeloma

Sep 26, 2019 - The FDA has approved daratumumab in combination with bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The approval is based on ...
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Larotrectinib Approved in Europe for NTRK+ Tumors

Sep 23, 2019 - The European Commission has approved larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result ...
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EU Panel Recommends 4-Week Nivolumab Dosing Schedule in Adjuvant Melanoma

Sep 24, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant ...
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