The Aliqopa Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s dive into the journey of Aliqopa (copanlisib) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case study provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Aliqopa (copanlisib) Mechanism of Action: PI3K inhibitor, which inhibits phosphatidylinositol-3-kinase, a […]
The Opdivo Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Opdivo (nivolumab) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case study provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Opdivo (nivolumab) Mechanism of Action: PD-1 inhibitor, which helps the immune […]