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Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...[ Price : $8.95]
IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neuro...[ Price : $8.95]
FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four m...[ Price : $8.95]
Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...[ Price : $8.95]
Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...[ Price : $8.95]
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...[ Price : $8.95]
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.[ Price : $8.95]
FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...