sabato, 3 giugno 2023

Notizie AIOM – anno XVII n. 729

FDA Approves Newly Designed Syringe for Lanreotide in GEP-NETs

June 24, 2019 - The FDA has granted an approval to a prefilled syringe for lanreotide, which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced ...
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One additional country to benefit from EU-US mutual recognition agreement for inspections

June 27, 2019 - On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing ...
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28 giugno 2019 – Registro Sonidegib (Novartis) – Attivazione web e pubblicazione schede di monitoraggio

FDA Approves Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma

June 27, 2019 - The FDA has approved the combination of daratumumab with lenalidomide and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). The approval, which was granted ...
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24 giugno 2019 – Nota Informativa Importante su biotina

24 giugno 2019 – Comunicazione EMA su medicinali contenenti leuprorelina

FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer

June 24, 2019 - The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior ...
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