lunedì, 4 maggio 2026

Notizie Newsletter

FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence

Aug 19, 2019 - Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work ...
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Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings

Aug 20, 2019 - As someone who has dedicated his life to reducing the public health burden and suffering caused by cancer, it is all too clear that we must do everything we can to prevent kids from starting down a path of a lifelong addiction to tobacco and its associated ...
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FDA Grants Enzalutamide Priority Review for Metastatic Hormone-Sensitive Prostate Cancer

Aug 21, 2019 - The FDA has granted a priority review designation to a supplemental new drug application for enzalutamide for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC), according to Astellas Pharma Inc. and Pfizer Inc., the codevelopers ...
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FDA Grants Zanubrutinib Priority Review for Relapsed/Refractory Mantle Cell Lymphoma

Aug 21, 2019 - The FDA has granted a priority review designation to a new drug application (NDA) for zanubrutinib (BGB-3111) for the treatment of patients with mantle cell lymphoma (MCL) who have received ≥1 prior therapy. The application is based on data from an international ...
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Elotuzumab Triplet Approaches EU Approval for Multiple Myeloma

July 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approving elotuzumab for use in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple ...
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Atezolizumab Plus Chemo Poised for EU Approval in Small Cell Lung Cancer

July 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of atezolizumab in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung ...
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EU Panel Backs Pembrolizumab Plus Axitinib for Frontline RCC

July 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of pembrolizumab in combination with axitinib for the frontline treatment of patients with advanced renal cell carcinoma (RCC). The CHMP based its ...
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Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel Nears EU Approval in Nonsquamous NSCLC

July 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to the triplet regimen of atezolizumab, carboplatin, and nab-paclitaxel for the first-line treatment of patients with advanced, nonsquamous ...
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Names of liposomal medicines to be changed to avoid medication errors

July 31, 2019 - All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to EU regulators a variation to change the names of these medicines as soon as possible before the end of September 2019. This recommendation ...
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NICE Approves Frontline Pembrolizumab Regimen for Squamous NSCLC

Aug 8, 2019 - The UK’s National Institute for Health and Care Excellence has authorized the use of pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the treatment of patients with metastatic squamous non–small cell lung ...
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