Drug Approval | October 27, 2022
USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
The CRL did not identify any outstanding scientific issues with the product.
The CRL did not identify any outstanding scientific issues with the product.
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
The company will review FDA's response and decide on appropriate next steps soon.
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