FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
U.S. Food and Drug Administration
New test provides less invasive option, reduces reliance on PET scans, and increases diagnosis accessibility
Articles by U.S. Food and Drug Administration
FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis
U.S. Food and Drug Administration
First home antibody test can inform patients of current or past infection and lead to confirmatory testing with healthcare provider
Disruptions in Availability of BD BACTEC Blood Culture Media Bottles—Letter to Healthcare Providers
U.S. Food and Drug Administration
The US is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues
First Point-of-Care Hepatitis C Test Authorized by FDA
U.S. Food and Drug Administration
The RNA-based test enables single-visit testing for HCV in about an hour, streamlining access to treatment
FDA Releases New Principles for Machine Learning-Enabled Medical Devices
U.S. Food and Drug Administration
The new guiding principles promote transparency to build trust and improve the user experience of machine learning-enabled medical devices
FDA Takes Aim at Ensuring the Safety and Effectiveness of Laboratory Developed Tests
U.S. Food and Drug Administration
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
FDA Approves New Antibiotic for Multiple Bacterial Infections
U.S. Food and Drug Administration
The FDA granted the approval of Zevtera® to Basilea Pharmaceutica International Ltd.
FDA Approves First Nonsteroidal Drug for DMD
U.S. Food and Drug Administration
The FDA granted the approval of Duvyzat™ to Italfarmaco S.p.A
FDA Approves First Gene Therapy for Metachromatic Leukodystrophy
U.S. Food and Drug Administration
The FDA granted approval of Lenmeldy™ to Orchard Therapeutics
FDA Approves First Treatment for NASH-Related Liver Scarring
U.S. Food and Drug Administration
The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals
FDA Clears First Over-the-Counter Continuous Glucose Monitor
U.S. Food and Drug Administration
Users should not make medical decisions based on the device’s output without talking to their healthcare provider
FDA Approves First Immunotherapy for Metastatic Skin Cancer
U.S. Food and Drug Administration
The FDA granted the approval of Amtagvi to Iovance Biotherapeutics Inc.
FDA Approves First Gene Therapies for Sickle Cell Disease
U.S. Food and Drug Administration
The FDA granted the approval of Casgevy to Vertex Pharmaceuticals Inc., and Lyfgenia to Bluebird Bio Inc.
FDA Approves First Drug Therapy for Desmoid Tumors
U.S. Food and Drug Administration
The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.
FDA Approves First Vaccine for Chikungunya Disease
U.S. Food and Drug Administration
Ixchiq is a single-dose, attenuated vaccine, safe to be administered to individuals above 18 years