March 21, 2025

Vutrisiran Receives FDA Nod for ATTR Amyloidosis With Cardiomyopathy

The FDA approves vutrisiran (Amvuttra) as the first RNAi therapeutic to reduce cardiovascular events and mortality in adults with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

Conexiant

March 19, 2025

Study Shows Widespread Delays in Medical Device Reporting to FDA

Late reporting was concentrated among a small number of manufacturers, with 3 manufacturers and 13 devices accounting for 54.8% of all late reports between 2019 and 2022.

Conexiant

March 18, 2025

Medtronic Recall: FDA Issues Highest-Risk Warning

The FDA has classified the recall of Medtronic’s Pipeline Vantage embolization devices as its most serious, citing risks of thrombosis, stroke, and death. The devices, used to treat brain aneurysms, have been linked to multiple patient injuries and fatalities.

Reuters

March 18, 2025

FDA Approves First Liquid Losartan Formulation

FDA approves Arbli (TM), the first ready-to-use losartan oral suspension for hypertension, stroke risk reduction, and diabetic nephropathy.

Conexiant

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 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

March 03, 2025

FDA Approves First New Stroke Thrombolytic in 30 Years

The FDA has approved tenecteplase for acute ischemic stroke, offering a faster and simpler administration compared to alteplase based on findings from the AcT trial.

Conexiant

February 27, 2025

CDC Investigating Hospitalizations After Chikungunya Vaccine

Health care providers are advised to assess the benefits and risks of the vaccine with each traveler.

Conexiant