Pins matching tag:FDA

Abbott began a medical device correction for about 3 million FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. after internal testing found some give incorrect low glucose readings, an issue it linked to 736 severe adverse events and seven deaths worldwide. The FDA later made it a Class I recall.

The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.

The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.

The FDA authorized Abbott's Libre Duo 10 Day, the first wearable to continuously track both glucose and ketones, which alerts people with diabetes aged 2 and older to rising ketones before diabetic ketoacidosis.

The FDA approved Abbott's TactiFlex Duo, a catheter that can deliver pulsed field ablation, radiofrequency energy or both in one procedure to treat complex atrial fibrillation. The approval rested on the FlexPulse IDE study.

An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.

The Senate HELP Committee questions Dr. Heidi Overton, President Trump's pick for FDA commissioner, at 10:30 a.m. ET in 430 Dirksen. If confirmed, the White House domestic policy aide would take over an agency that has lost more than 3,000 staff in the past year.

Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.