domenica, 3 maggio 2026

Notizie AIOM – anno XVII

21 Novembre 2019

Frontline Daratumumab Triplet Approved in EU for Transplant-Ineligible Myeloma

November 19, 2019 - The European Commission has approved the triplet regimen of daratumumab with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval, ...
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21 Novembre 2019

Pembrolizumab Regimens Approved in EU for Frontline PD-L1+ HNSCC

November 20, 2019 - The European Commission has approved pembrolizumab as a monotherapy or in combination with platinum and 5-FU chemotherapy for the frontline treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) and ...
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19 Novembre 2019

A first version of the Pan-European Indoor Radon Map

A hypothetical Pan-European Indoor Radon Map has been developed using summary statistics estimated from 1.2 million indoor radon samples. In this study we have used the arithmetic mean (AM) over grid cells of 10 km × 10 km to predict a mean indoor radon concentration ...
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18 Novembre 2019

Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

November 15, 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, ...
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18 Novembre 2019

‘Regulatory science to 2025’: live broadcast of post-consultation workshop

November 11, 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its draft ‘Regulatory Science Strategy to 2025’ on 18-19 November. The draft strategy sets out working proposals on the key areas with which ...
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18 Novembre 2019

Dutch authorities hand over final building to EMA in Amsterdam

November 15, 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s Executive Director, signed the lease agreement and thanked the Dutch authorities for reaching this ...
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18 Novembre 2019

Adjuvant T-DM1 Approaches EU Approval for HER2+ Early Breast Cancer

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual ...
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18 Novembre 2019

Lenalidomide/Rituximab Combo Nears EU Approval for Follicular Lymphoma

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the combination of lenalidomide and rituximab for the treatment of adult patients with grade 1 to 3a previously treated follicular lymphoma. The ...
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18 Novembre 2019

EU Panel Backs Polatuzumab Vedotin Approval for DLBCL

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the antibody-drug conjugate (ADC) polatuzumab vedotin for use in combination with bendamustine and rituximab (BR) for the treatment ...
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18 Novembre 2019

Fostamatinib Slated for EU Approval in Chronic ITP

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate (fostamatinib) for the treatment of adult patients ...
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