The Trudhesa Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Trudhesa (dihydroergotamine mesylate) 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: Trudhesa (dihydroergotamine mesylate) Mechanism of Action: Serotonin receptor agonist, which constricts […]
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 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 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 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 Zolgensma Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Zolgensma (onasemnogene abeparvovec) 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: Zolgensma (onasemnogene abeparvovec) Mechanism of Action: Gene therapy that delivers […]
The Evenity Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Evenity (romosozumab) 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: Evenity (romosozumab) Mechanism of Action: Sclerostin inhibitor, which increases bone formation and […]
The Balversa Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s dive into the journey of Balversa (erdafitinib) 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: Balversa (erdafitinib) Mechanism of Action: FGFR (fibroblast growth factor receptor) inhibitor, […]