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Support for FDA Biosimilar Comparative Studies Draft Guidance

[ Price : $8.95]

Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...

IntraBio Reports Positive Phase 3 Data on Levacetylleucine

[ Price : $8.95]

IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neuro...

FDA Touts ImportShield Results

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FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four m...

AdvaMed Urges FDA to Narrow Guidance on Device QMS

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Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...

Cogent Bio Plans NDA for Bezuclastinib

[ Price : $8.95]

Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...

Moderna/Merck Report Positive Data on Melanoma Vaccine

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Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...

Objectionable Conditions in Prodrome Sciences BIMO Inspection

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FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.

Guide on Endpoints for Multiple Myeloma Accelerated Approval

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FDA posts a draft guidance outlining how drug developers can use minimal residual disease and complete response as primary endpoin...

Novo Nordisk Supplements Semaglutide Petition

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Novo Nordisk submits to FDA additional studies and analyses it says support its petition asking the agency to act against compound...

FDA Seeks More Data on Capricor Cell Therapy

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FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA ...