FDA/CDC
FDA/CDC
FDA authorizes booster shot for immunocompromised Americans
Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases...
FDA/CDC
FDA warns of potential mechanical concerns with MAGEC devices
MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis in children under 10 years of age.
FDA/CDC
FDA to warn J&J that vaccine can increase Guillain-Barré risk: Media
The agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk.
FDA/CDC
CDC: Vaccinated? You don’t need a mask indoors
FDA/CDC
CDC recommends use of Pfizer’s COVID vaccine in 12- to 15-year-olds
ACIP voted 14-0 in favor of the safety and effectiveness of the vaccine in younger teens.
FDA/CDC
CDC: Vaccinated people can mostly drop masks outdoors
It is a minor – but still significant – step toward the end of pandemic restrictions.
FDA/CDC
FDA panel supports islet cell treatment for type 1 diabetes
Voting 12-4 to support approval, panel members expressed concern about toxicity of long-term immunosuppression, particularly given the advances in...
FDA/CDC
Medtronic recall of almost 240,000 ICDs is class I, FDA says
The recall applies to implantable defibrillators, with and without resynchronization pacing, that are at apparent risk for premature and possibly...
FDA/CDC
FDA, CDC urge pause of J&J COVID vaccine
Treatment for traditional blood clots, such as the drug heparin, should not be used for these clots.
FDA/CDC
OCS heart system earns hard-won backing of FDA panel
The nonbinding vote moves forward the device, which advocates hailed as a potentially transformative step for heart transplantation.
FDA/CDC
FDA okays transcatheter pulmonary valve for congenital heart disease
Medtronic’s Harmony valve is the first minimally invasive option for patients with severe pulmonary valve regurgitation who have a native or...