Articles related to FDA

The FDA approved Furoscix ReadyFlow, a subcutaneous furosemide autoinjector for edema associated with heart failure or chronic kidney disease. Clinical data demonstrated pharmacokinetic exposure and diuretic effects comparable to intravenous furosemide.

The FDA approved Lytenava as the first ophthalmic bevacizumab formulation for wet AMD. The decision moves bevacizumab beyond repackaged intravenous use, with launch logistics still pending.

The FDA issued a Class II recall for an amphetamine-based ADHD medication after a labeling mix-up resulted in immediate-release capsules being packaged as extended release. The recall affects a single lot totaling 1,392 bottles.

The FDA approved centanafadine for ADHD in adults and children aged 6 years and older, introducing the first approved norepinephrine, dopamine, serotonin reuptake inhibitor for the disorder. Approval was based on phase 3 trial results and regulatory review.

The FDA approved enlicitide (Lipfendra), the first oral PCSK9 inhibitor for lowering LDL cholesterol in adults with hypercholesterolemia. Approval was based on substantial LDL-C reductions, while cardiovascular outcomes data remain pending.

A Phase 2 trial of luvesilocin reported rapid reductions in postpartum depression symptoms, with most treated participants reaching remission within seven days. The investigational psychedelic has received FDA Breakthrough Therapy designation, but Phase 3 confirmation remains pending.