March 13, 2025

FDA Chief Counsel Resigns Two Days In

U.S. FDA's chief counsel resigns amidst controversy surrounding her appointment and connections to mifepristone during the Biden administration.

Reuters

March 10, 2025

AI Methods Strengthen Real-World Data Reliability

Researchers assessed the impact of AI-driven methods on real-world data reliability, showing improvements in accuracy, completeness, and traceability

Conexiant

March 05, 2025

FDA Monthly Round-Up: Key February Updates

February's FDA approvals feature advancements in cardiology, neurology, infectious diseases, and rare disorders, including the first trials for genetically modified pig kidney transplants and novel treatments for Parkinson’s disease and spinal muscular atrophy.

Conexiant

March 03, 2025

More States Fast Track Foreign-Trained Physicians

Since 2023, nine states have waived U.S. residency requirements for some foreign-trained physicians, with more states considering similar changes.

KFF Health News

February 25, 2025

FDA Delays Update on 'Healthy' Label

The finalization of new criteria for the "healthy" nutrient content claim on food labels has been delayed, allowing more time for regulatory review of standards that could significantly influence labeling practices and help reduce diet-related chronic diseases.

Conexiant

February 21, 2025

FDA Approves First Cerebrotendinous Xanthomatosis Treatment

The FDA has approved Ctexli (chenodiol) as the first treatment for cerebrotendinous xanthomatosis, a rare lipid storage disorder.

Conexiant

February 21, 2025

FDA Ends Semaglutide Shortage, Updates Policy

FDA declares resolution of nationwide semaglutide injection shortage and outlines 60 to 90 day transition periods for compounding facilities while other GLP-1 medications remain in limited supply.

Conexiant

February 19, 2025

FDA Approves Amneal’s Lenalidomide; Mesalamine 800 mg Launched

Mesalamine 800 mg delayed-release tablets have been launched, and FDA approval has been granted for lenalidomide, with plans for entry into the U.S. generic market in 2026.

Conexiant

July 18, 2023

First Oral Medication to Treat Moderate-to-Severe Crohn’s Disease Earns FDA Approval

Upadacitinib, the first oral treatment for Crohn's disease, has been approved by the Food and Drug Administration. The approval came in part through a Mount Sinai-led clinical trial that showed it to be more efficacious than placebo.

Mount Sinai New York