Author: Jackie Orabone

Artificial Intelligence | FDA | Uncategorized

Unlocking the Potential of Digital Health Therapeutics: FDA-Approved Solutions for Modern Healthcare
ByJackie Orabone June 23, 2025June 23, 2025

Digital health therapeutics (DTx), applications increasingly powered by AI and/or machine learning, are on the rise and promise to increase access to healthcare, provide real-time monitoring of health data, improve patient engagement and adherence to treatment, and reduce healthcare costs. What Are Digital Health Therapeutics? DTx are evidence-based therapeutic interventions driven by software and technology…

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FDA

Rare Disease Day 2024
ByJackie Orabone February 27, 2024February 28, 2024

This year, Rare Disease Day is on February 29, 2024. Rare Disease Day is observed on the last day of February, which is the “rarest of calendar dates1 to underscore the nature of these diseases” and serves to raise awareness of rare diseases and those individuals affected by them. FDA is holding a virtual meeting2…

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Advisory Committees | FDA | ProEd Regulatory

Landmark Approval: First CRISPR Therapy Approved by FDA
ByJackie Orabone December 8, 2023February 27, 2024

Today, the US Food and Drug Administration (FDA) approved exagamglogene autotemcel (exa‑cel), the first CRISPR-based gene therapy for the treatment of sickle cell disease (SCD). Exa‑cel was co-developed by Vertex Pharmaceuticals and CRISPR Therapeutics. This is a landmark approval that paves the way not only for better outcomes for patients with SCD, but for many…

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Clinical Trials | ProEd Regulatory | Uncategorized

Quick Snips: CRISPR
ByJackie Orabone June 22, 2023February 27, 2024

CRISPR is a powerful gene-editing tool that enables targeted therapeutic gene editing, with clinical applications for improving treatment of inherited and/or rare genetic diseases, viral infections, and arresting the progression of cancer. CRISPR gene-editing technology has the potential to revolutionize the treatment of rare genetic disorders, with the first product poised for FDA approval in…

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ProEd Regulatory

Introduction to the Accelerated Approval Pathway
ByJackie Orabone March 21, 2022March 22, 2022

The FDA has developed several mechanisms to speed drugs to market when a compelling medical need exists including Accelerated Approval (AA), Priority Review, Fast Track, and Breakthrough Therapy Designation. Accelerated Approval is an important regulatory pathway that provides patients with earlier access to treatments for serious medical conditions when there is an unmet medical need….

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