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