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Latest From DBV Technologies

BMS’ Cell Therapy For Lymphoma On Track For EU-Wide Approval

Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week. 

Gene Therapy Approvals

DBV Pulls EU Peanut Allergy Patch Filing To Work On A Stronger Application

Following regulatory setbacks in the US and also now in the EU, DBV Technologies is to conduct a new pivotal trial of a modified version of its peanut allergy patch to support its efforts to win marketing approval.

Drug Review Regulation

When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

Drug Review Review Pathway

Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.

Approvals Review Pathway
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