venerdì, 14 marzo 2025

Notizie AIOM – anno XVII

FDA Approves Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With ALL

December 20, 2018 - On December 20, 2018, the U.S. Food and Drug Administration (FDA) approved calaspargase pegol-mknl (Asparlas), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and ...
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Responding to emerging health threats in the EU

December 17, 2018 - EMA has published a plan outlining how it would respond to an emerging cross-border threat to health, such as an influenza pandemic. The threats plan is based on the Agency’s pandemic influenza plan published in 2006 and reflects experience gained ...
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Adjuvant Pembrolizumab Approved in EU for Stage III Melanoma

December 17, 2018 - The European Commission has approved pembrolizumab as an adjuvant treatment for patients with resected, stage III melanoma with lymph node involvement, according to Merck (MSD), the manufacturer of the PD-1 inhibitor. The approval was based on findings ...
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Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics Guidance for Industry

This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. ...
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