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
Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation
This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…
CertaraNovember 5, 2025
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
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
Certara Launches DIDB® Concomitant Meds Navigator, Extending Leadership in Drug Interaction Science
Meet DIDB Concomitant Meds Navigator—an evidence-based tool to identify contraindicated or monitored co-medications and manage…
CertaraSeptember 22, 2025
FAQs on Developing EMA Policy 0070 Submissions
This blog answers audience questions posed during our RAPS webinar, How to Plan for a…
CertaraSeptember 15, 2025
