Articles related to DEVICE/DRUG APPROVALS

The FDA approved a low-estrogen weekly contraceptive patch for pregnancy prevention in eligible women with BMI below 30 kg/m². Approval was supported by Phase 3 efficacy, safety, and adhesion data, but use remains subject to established combined hormonal contraceptive contraindications.

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 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.