Articles related to FDA

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.

The FDA expanded approval of the CRISPR-based gene therapy Casgevy to include patients as young as 2 years with sickle cell disease or transfusion-dependent beta thalassemia. The decision was supported by pediatric phase 3 data demonstrating sustained reductions in disease burden.

The FDA approved enlicitide, the first oral PCSK9 inhibitor, after phase 3 studies demonstrated substantial LDL-C reductions in patients requiring additional lipid lowering. Cardiovascular outcomes data remain pending.

The FDA classified the nationwide recall of more than 2.5 million bottles of Lupin’s prednisolone acetate ophthalmic suspension as a Class II recall after reports of a foreign substance in affected products.