The Voxzogo Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Voxzogo (vosoritide) 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: Voxzogo (vosoritide) Mechanism of Action: C-type natriuretic peptide (CNP) analog that promotes […]
The Evrysdi Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Evrysdi (risdiplam) 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: Evrysdi (risdiplam) Mechanism of Action: Survival of motor neuron 2 (SMN2) splicing […]
The Nurtec ODT Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s dive into the journey of Nurtec ODT (rimegepant) 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: Nurtec ODT (rimegepant) Mechanism of Action: CGRP (calcitonin gene-related peptide) […]
The Rinvoq Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s dive into the journey of Rinvoq (upadacitinib) 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: Rinvoq (upadacitinib) Mechanism of Action: Janus kinase (JAK) inhibitor, which helps […]
The Jardiance Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Jardiance (empagliflozin) 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: Jardiance (empagliflozin) Mechanism of Action: Sodium-glucose co-transporter 2 (SGLT2) inhibitor, which […]