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
U.S. FDA Proposed Rule on Laboratory-Developed Tests
Erica Conway, PhD
The FDA faces a quandary—increasing oversight of LDTs to protect public health without affecting the quality of patient care
FDA Proposed Rule on LDT Regulation: Comments Due Soon
Shannon Bennett, MS, MBA
Clinical laboratories should strongly consider submitting comments before the Dec. 4 deadline
MS Biomarker Test Gets Breakthrough Device Designation
Swathi Kodaikal, MSc
Blood NfL levels can provide insights into neurological conditions such as Alzheimer’s, Parkison’s, and Huntington’s diseases
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
FDA Approves Recombinant Enzyme to Treat Rare Blood Clotting Disorder
U.S. Food and Drug Administration
Adzynma safely and effectively “filled in” for the mutated ADAMTS13 enzyme in patients with cTTP
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
U.S. Food and Drug Administration
Wezlana has similar safety and efficacy as its reference product and is a cost-effective alternative for chronic inflammation
FDA Approves Steroid-Like Drug for Duchenne Muscular Dystrophy
Children's National Hospital
Vamorolone offers a new treatment option with fewer side effects
FDA Approves New Therapeutic for Myelodysplastic Syndromes
U.S. Food and Drug Administration
Tibsovo can be used with FDA-approved companion diagnostic RealTime IDH1 Assay to detect and treat MDS
Response: FDA Proposes Rule to Ensure Safety and Effectiveness of LDTs
Kathryn Golab, MLS(ASCP)CM
The proposed change in LDT regulation may not be as straightforward as it seems