NIH-Funded Multi-Center Trial Shows Reversal of Cognitive Decline Markers in Early Alzheimer's Patients
Researchers from the National Institutes of Health and leading university medical centers have published Phase III clini...
Health
Commentary, explainers, and curated reading notes
FEATURED • HealthFDA Unveils Regulatory Framework to Accelerate AI-Driven Clinical Drug Trials for Rare Diseases
The U.S. Food and Drug Administration issued new regulatory guidance permitting pharmaceutical developers to utilize validated synthetic patient control arms and computational biological modeling to accelerate life-saving therapeutics for orphan and rare genetic diseases.
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FDA Approves Landmark Personalized mRNA Cancer Immunotherapy for Melanoma and Lung Tumors
The Food and Drug Administration has granted approval for the first personalized mRNA-based cancer immunotherapy designe...
What a Targeted-Therapy Clinical Trial Can Actually Prove
The phase, comparator, endpoint, effect size, safety profile, and patient population determine whether “breakthrough” is...
How to Use Seasonal Respiratory Guidance
Public-health guidance should be read by date, audience, risk group, setting, and local transmission conditions.
How to Read a Preventive-Health Study Without Overstating It
A study can identify an association or test an intervention without proving that one habit will prevent disease for ever...
How to Check Whether a New FDA Labeling Rule Applies to You
FDA proposals, final rules, guidance, compliance dates, and product-specific labeling changes are not interchangeable.
How to Interpret Studies Linking Everyday Activity and Heart Health
Activity studies can be informative while still being affected by measurement error, reverse causation, confounding, and...
How to Evaluate Claims About Non-Invasive Early Detection
A promising diagnostic test must demonstrate accuracy, clinical utility, appropriate follow-up, and acceptable harm in t...