Content by U.S. Food and Drug Administration
|2 min read
FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
The FDA has approved Hepcludex, the first treatment for chronic hepatitis D virus infection, offering a new option for patients at risk of severe liver complications
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FDA Launches Initiative to Advance Drug Repurposing for Unmet Medical Needs
The agency is particularly focused on new uses to treat chronic or rare diseases, substance use disorders
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FDA Announces Major Steps to Implement Real-Time Clinical Trials
Agency unveils real-time trial proofs-of-concept and upcoming pilot program
|3 min read
FDA Fast-Tracks Ultra-Rare Therapies with Plausible Mechanism Guidance
Framework enables approval of individualized genome editing and RNA-based treatments when traditional trials aren’t feasible
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FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
New test provides less invasive option, reduces reliance on PET scans, and increases diagnosis accessibility
|3 min read
FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis
First home antibody test can inform patients of current or past infection and lead to confirmatory testing with healthcare provider
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Disruptions in Availability of BD BACTEC Blood Culture Media Bottles—Letter to Healthcare Providers
The US is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues
|3 min read
First Point-of-Care Hepatitis C Test Authorized by FDA
The RNA-based test enables single-visit testing for HCV in about an hour, streamlining access to treatment
|3 min read
FDA Releases New Principles for Machine Learning-Enabled Medical Devices
The new guiding principles promote transparency to build trust and improve the user experience of machine learning-enabled medical devices
|5 min read
FDA Takes Aim at Ensuring the Safety and Effectiveness of Laboratory Developed Tests
The FDA announced a final rule amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act
Updated |3 min read
FDA Approves New Antibiotic for Multiple Bacterial Infections
The FDA granted the approval of Zevtera® to Basilea Pharmaceutica International Ltd.
|2 min read
