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Latest From DBV Technologies
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.
The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.
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