FDA/CDC
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
How some COVID-19 vaccines could cause rare blood clots
Six cases of a rare but serious event in patients who got the J&J vaccine are being reviewed.
FDA/CDC
FDA to recommend limits on heavy metals in baby foods
Called “Closer to Zero,” the FDA plan calls for continued scientific investigation, establishes acceptable levels of heavy metals, sets up a way...
FDA/CDC
FDA lifts in-person dispensing requirement for mifepristone
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as...
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.
News
FDA approves first AI device to detect colon lesions
The GI Genius works in conjunction with an endoscope during colonoscopy, highlighting possible polyps.
News
FDA approves new ready-to-inject glucagon product
Dasiglucagon is the third of newer-generation glucagon products that don’t require multistep reconstitution in emergency hypoglycemic situations...
FDA/CDC
FDA okays new indication for alirocumab in homozygous FH
The FDA approved use of the PCSK9 inhibitor as an add-on therapy in adults with rare homozygous familial hypercholesterolemia.