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 Livmarli Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Livmarli (maralixibat) 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: Livmarli (maralixibat) Mechanism of Action: Apical sodium-dependent bile acid transporter (ASBT) inhibitor, […]
The Empaveli Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Empaveli (pegcetacoplan) 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: Empaveli (pegcetacoplan) Mechanism of Action: Complement inhibitor that binds to complement protein […]
The Klisyri Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Klisyri (tirbanibulin) 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: Klisyri (tirbanibulin) Mechanism of Action: Microtubule inhibitor, which disrupts cellular processes essential […]
The Zynlonta Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Zynlonta (loncastuximab tesirine-lpyl) 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: Zynlonta (loncastuximab tesirine-lpyl) Mechanism of Action: Antibody-drug conjugate (ADC) targeting […]