Therapeutic Specialties Archives

Announcement

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.

CertaraDecember 3, 2025

Blog

Using M&S to Evaluate Oncology Drug Dosing

Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…

CertaraNovember 14, 2025

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

CertaraNovember 12, 2025

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

CertaraOctober 31, 2025

Case Study

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…

CertaraOctober 2, 2025

Conference

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

CertaraSeptember 22, 2025

Press Coverage

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

Explore the top challenges in cell & gene therapy commercialization, featuring expert insights from Fran…

CertaraSeptember 12, 2025

Conference

The Pharmacometrics Africa Conference 2025 (PMXAC-2025)

CertaraSeptember 4, 2025

Therapeutic Specialties

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Using M&S to Evaluate Oncology Drug Dosing

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

The Pharmacometrics Africa Conference 2025 (PMXAC-2025)

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