Healio

FDA approves orforglipron, an oral GLP-1, for adults with obesity

The FDA approved a once-daily oral GLP-1 receptor agonist for adults with obesity or overweight with weight-related comorbidities, Eli Lilly announced.
Endovascular Today

Getinge’s iCast Covered Stent System Receives FDA Approval for New Sizes

Getinge announced it has received FDA premarket approval for additional sizes of its iCast covered stent system. The approval incl

Vertex Announces US FDA Approval for Label Extensions of ALYFTREK® and TRIKAFTA®, Expanding Availability of These Medicines to ~95% of All People With CF in the United States

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK® (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.
Healio

FDA approves once-weekly basal insulin for adults with type 2 diabetes

The FDA approved a once-weekly, long-acting basal insulin for adults with type 2 diabetes as an alternative to daily basal insulin, Novo Nordisk announced. Insulin icodec-abae (Awiqli, Novo Nordisk) is a 700 U/mL injectable insulin approved as an adjunct to diet and exercise to improve glycemic control for adults with type 2 diabetes.
Fierce Pharma

FDA approves Denali's Hunter syndrome drug, handing rare disease community a win

The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates. In approving Denali’s tividenofusp alfa,
FoodNavigator-USA

FDA delays beetroot red and spirulina color approvals after safety and labeling worries

FDA has delayed the effective dates for beetroot red and spirulina extract color additives after GMO/Toxin Free USA and Obelisk Tech Systems filed safety objections.
Yahoo Finance

i-Lumen Scientific Receives FDA Approval of IDE to Initiate U.S. Enrollment in i-SIGHT2 Clinical Study for dry AMD

IDE approval by the FDA expands global trial to the United States as first study participant is treated in the United Kingdom BLOOMINGTON, Minn., March 31, 2026 /PRNewswire/ -- i-Lumen Scientific, Inc., a leader in energy-based innovations for ...