Articles related to DEVICE/DRUG APPROVALS

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.

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 cefepime-zidebactam (Zaynich) for complicated UTI and pyelonephritis caused by susceptible gram-negative organisms. Approval followed phase 3 trial data showing higher rates of symptom and microbiologic resolution compared with meropenem in hospitalized adults.

The FDA has approved the first generic version of baloxavir marboxil, a single-dose influenza antiviral noninferior to oseltamivir, ahead of the 2026-2027 flu season.

An EEG-guided neuromodulation system received FDA clearance for PTSD treatment based on a randomized controlled trial. The platform uses individualized brain activity data to guide therapy, though detailed efficacy results have not been disclosed.