September 2026 FDA drug approvals at a glance

Notable approvals

September’s standout approvals changed cancer treatment planning and brought new options for Parkinson’s and kidney disease. Etcamah (camizestrant) makes molecular monitoring actionable in breast cancer, allowing an endocrine therapy switch before disease progression when an ESR1 resistance mutation emerges during aromatase inhibitor plus CDK4/6 inhibitor therapy. Hyrnuo (sevabertinib) brings an oral targeted option into first-line treatment for advanced HER2-mutated lung cancer, reinforcing the importance of molecular testing at diagnosis.

Juvmo (tavapadon) introduces a distinct approach to Parkinson’s motor symptoms as the first selective D1/D5 dopamine agonist, used alone or alongside levodopa. Kerendia (finerenone) expands treatment for CKD associated with type 1 diabetes beyond ACE inhibitors or ARBs, offering an additional way to reduce persistent albuminuria after decades with few new options. Gazyva (obinutuzumab) adds the first new approved option for idiopathic nephrotic syndrome in 70 years, improving relapse prevention in frequently relapsing or steroid-dependent, childhood-onset disease.

Several September approvals addressed unmet needs in rare diseases, offering first treatments where care had been largely supportive and new options for debilitating symptoms that persist despite existing therapy. Zanvastro (zilganersen) treats Alexander disease, while Fayuvi (rebisufligene etisparvovec-hopf) offers gene therapy for eligible children with Sanfilippo syndrome type A who retain neurodevelopmental function. Isembyld (apitegromab) adds the first treatment directed at muscle loss in spinal muscular atrophy, improving motor function alongside existing therapies that protect the nerve cells controlling movement. Emcitate (tiratricol) became the first approved therapy for peripheral thyrotoxicosis in MCT8 deficiency. With its new indication, Aqneursa (levacetylleucine) provides the first approved option for treating ataxia in ataxia-telangiectasia.

Additional approvals

• Inluriyo (imlunestrant) plus Verzenio (abemaciclib): Approved for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer after progression on at least one line of endocrine therapy.
• Welireg (belzutifan) plus Lenvima (lenvatinib): Approved for advanced kidney cancer with a clear-cell component after PD-1 or PD-L1 inhibitor therapy.
• Camzyos (mavacamten): Expanded to pediatric patients weighing at least 30 kg with symptomatic obstructive hypertrophic cardiomyopathy, to improve symptoms and functional capacity.
• Lyrfigtu (lirafugratinib): Approved for previously treated advanced bile duct cancer with FGFR2 fusions or rearrangements.
• Onswik (insulin efsitora alfa): Another once-weekly basal insulin for adults with type 2 diabetes.
• Olumiant (baricitinib): Expanded severe alopecia areata treatment to adolescents aged 12 years and older.
• Atebrioz (zilurgisertib): Approved to reduce new bone formation outside the skeleton in patients aged 12 years and older with fibrodysplasia ossificans progressiva.
• Joenja (leniolisib): Expanded treatment of activated PI3K-delta syndrome to children aged 4–11 years weighing at least 27 kg.
• Pixclara (floretyrosine F 18): A PET imaging drug that helps distinguish recurrent or progressing glioma from treatment-related changes.
• Ameluz (aminolevulinic acid hydrochloride): New indication for superficial basal cell carcinoma in adults, used with BF-RhodoLED red-light photodynamic therapy.
• Degevma (denosumab-adet): A biosimilar to Xgeva for cancer-related bone conditions.
• Bexlutry and Bravnetsa: Additional lutetium Lu 177 dotatate products for gastroenteropancreatic neuroendocrine tumors.