sabato, 15 agosto 2026

Notizie AIOM – anno XVII n. 731

FDA Approval Sought for Subcutaneous Daratumumab in Multiple Myeloma

July 12, 2019 - A supplemental biologics license application (sBLA) has been submitted to the FDA for a new subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma. The sBLA is based on findings from the phase III COLUMBA (MMY3012) study, ...
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PRAC recommends new measures to avoid dosing errors with methotrexate

July 12, 2019 - EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly. The new measures include restricting who can prescribe these ...
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

July 12, 2019 - With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in ...
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12 luglio 2019 – Comunicazione EMA su medicinali a base di ciproterone

12 luglio 2019 – Comunicazione EMA su metotrexato

12 luglio 2019 – Uso dei farmaci in Italia: AIFA presenta il Rapporto Nazionale 2018

13 luglio 2019 – Farmaci falsificati: AIFA, in Italia nessuna segnalazione

FDA Grants Durvalumab Orphan Drug Status in Small Cell Lung Cancer

July 12, 2019 - The FDA has granted an Orphan Drug Designation to durvalumab for the treatment of patients with small cell lung cancer (SCLC), according to AstraZeneca, the developer of the PD-L1 inhibitor. The designation follows the announcement of the phase III CASPIAN ...
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Medicaid Patients Need Clinical Trial Access, Coalition Tells Congress

July 10, 2019 - Today, organizations representing patients, providers, medical researchers, survivors, and their families joined together to call on Congress to improve access to clinical trials for patients with life-threatening diseases. The coalition, which is made up ...
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FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

July 9, 2019 - The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. The new dosage would be applicable for the PD-1 inhibitor’s ...
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