In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older. Voxelotor is an oral therapy taken once daily, it...
Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and the disease. In 2012, FDA approved Ivacaftor (Kalydeco®) for treatment of the underlying cause of CF in a small subset of the patient population. In...
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of...
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second submission we supported for this Sponsor in the overall partnership. The agile nature of the submission meant the Certara team would need to be strategic,...
Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams is a time-consuming, expensive, and often decentralized process. BaseCase is “no-code” platform that enables you to visualize large complex datasets and economic models, which demonstrates...
In Raj’s Corner, we’ve assembled a series of expert blog posts that will explain drug development best practices that support the most streamlined and informative clinical development program, to maximize the returns of investment of your program.
Learn how the FDA assessment aid streamlines oncology NDA/BLA reviews, what to include, and best practices to improve regulatory clarity and efficiency.
This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics, Long Island University, NY, USA. Here is a summary of his presentation: • Tizanidine is an alpha2-adrenergic agonist, used to treat spasticity associated with multiple...
Increase the efficiency of regulatory and medical writing with Certara’s purpose-built Generative AI-Enabled Writing Software.
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare B-cell malignancies to market. The company leveraged FDA’s accelerated approval program; it was one of the first to be awarded breakthrough status by the agency....
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