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Cell & Gene Therapy Diagnostic Interfaces

Preparing blood samples related to sickle cell disease treatment
|2 min read

FDA Expands Casgevy Gene Therapy to Children 2+ with Sickle Cell Disease and β Thalassemia

FDA approval extends CRISPR-based Casgevy to pediatric patients aged 2 and older, broadening access for sickle cell disease and transfusion-dependent β thalassemia.
byToday's Clinical Lab
The continued evolution of clinical trials depends on their integration with comprehensive training, structured statistical planning, and effective communication.
|3 min read

Ensuring Endpoint Integrity in Complex Clinical Trials

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|1 min read

The Path to Absolute Quantification in Gene Expression

Despite ongoing efforts to improve it, around 90 percent of clinical drug development still fails.
|3 min read

Regulating the Future: How the FDA Is Defining the Role of AI in Clinical Development

The FDA is embracing a data-driven, patient-centered approach to clinical trials
byGen Li, PhD, MBA
Here’s a quick roundup of the stories that captured the most attention in 2025.
|2 min read

TLDR; Our Top Stories of 2025

From regulatory shifts to breakthrough diagnostics, the stories that defined clinical labs in 2025
byToday's Clinical Lab
Instead of relying solely on clinical endpoints over extended treatment periods, the research examined whether molecular signals could reveal pharmacodynamic activity within the first few days of treatment.
|2 min read

Rapid Transcriptomics Brings Actionable Data to Early-Phase Topical Trials

Early transcriptomic readouts reveal pharmacodynamic activity in skin within days—a shift toward earlier molecular decision-making
byStéphanie Légaré, PhD
The introduction of electronic data capture (EDC) has streamlined workflows while giving sponsors cleaner data and reducing reconciliation challenges.
|4 min read

The Real-World Points of Value for Site-To-Lab Data Digitalization

While most clinical trial processes have gone digital, site-to-lab data capture still lags behind. Here’s why that matters and what’s changing
byKelli Aufderheide andGavin Hershaw
The younger patients, especially those between the ages of five and eight, responded best to the treatment.
|2 min read

Gene Therapy Restored Hearing in Deaf Patients

New gene therapy well-tolerated and improves hearing in all 10 patients with congenital deafness or severe hearing impairment
byKarolinska Institutet
Medications that block checkpoints, called immune checkpoint inhibitors, have become powerful tools for treating cancer.
Updated |3 min read

Releasing a Molecular ‘Brake’ May Help Immune Cells Better Fight Cancer

New findings could lead to better cancer immunotherapies by helping develop new drugs or T cell treatments to boost immune response
byVan Andel Research Institute
Leveraging the strengths of both companies, the joint research will focus on developing new methodologies to enhance the efficacy of Tregs and TILs in therapeutic applications.
|2 min read

Xcell Biosciences Announces Joint Research Collaboration with Thermo Fisher Scientific to Advance the Next Generation of Cell Therapies

Strategic collaboration to innovate Treg and TIL therapies, streamline cell therapy workflows, and enhance manufacturing efficiency
byXcell Biosciences
One particularly valuable source of this information for pharma, medical technology, and regulatory professionals conducting literature reviews is clinical trials data.
|3 min read

Unlocking Clinical Trial Data: Driving Smarter Decisions in Safety, Compliance, and Trial Design

Learn how structured, centralized clinical data is accelerating evidence-based decisions
byMirit Eldor, LLB, MBA
The custom solutions program aims to build new, bespoke tools and solutions that serve as a springboard for customer innovation, enabling them to design, build, test, and iterate more quickly.
|2 min read

Integrated DNA Technologies Installs Custom Solutions Program to Accelerate Innovation in Synthetic Biology

White glove manufacturing service aims to enhance design-build-test cycle and drive rapid innovation
byIntegrated DNA Technologies
Photo of two HIV vaccine glass vials and a syringe against a light blue background.
|5 min read

2 HIV Vaccine Trials Show Proof of Concept for Pathway to Broadly Neutralizing Antibodies

North American and African clinical trials led by Scripps Research, IAVI, and additional collaborators across the US and Africa mark progress toward an effective HIV vaccine
byThe Scripps Research Institute
Data from studies conducted in more than 200 countries supports greater access to research and facilitates systematic reviews, clinical trial design, medical device approvals, and improved drug safety
|2 min read

Elsevier Adds Half a Million Records from ClinicalTrials.gov to Embase Biomedical Database

Data from studies conducted in more than 200 countries supports greater access to research and facilitates systematic reviews, clinical trial design, medical device approvals, and improved drug safety
byElsevier
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Ensuring Compliance: How to Get AI Diagnostic Tools Approved for Clinical Practice

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The Path to Absolute Quantification in Gene Expression

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