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 […]