The Lumakras Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Lumakras (sotorasib) 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: Lumakras (sotorasib) Mechanism of Action: KRAS G12C inhibitor, which targets a specific […]
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 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 Viltepso Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Viltepso (viltolarsen) 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: Viltepso (viltolarsen) Mechanism of Action: Antisense oligonucleotide that binds to exon 53 […]
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 […]
The Orladeyo Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Orladeyo (berotralstat) 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: Orladeyo (berotralstat) Mechanism of Action: Kallikrein inhibitor, which prevents attacks of hereditary […]
The Rukobia Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Rukobia (fostemsavir) 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: Rukobia (fostemsavir) Mechanism of Action: Attachment inhibitor that prevents the HIV-1 virus […]
The Koselugo Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Koselugo (selumetinib) 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: Koselugo (selumetinib) Mechanism of Action: MEK inhibitor, which targets the mitogen-activated protein […]
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 […]