October 2026 FDA drug approvals at a glance

Notable Approvals

October’s standout approvals offered ways to reduce treatment burden, introduced new approaches to persistent viral infections, and expanded biomarker-guided cancer care. Weltruza (olanzapine) offers once-monthly subcutaneous treatment for adults with schizophrenia without required post-injection observation or oral supplementation, removing practical barriers to long-acting olanzapine use. Awiqli (insulin icodec-abae) became the first once-weekly basal insulin approved for children aged 10 years and older with type 2 diabetes, reducing basal injections from seven to one each week. Skyrizi (risankizumab-rzaa) now allows adults with moderately to severely active Crohn’s disease to begin treatment with subcutaneous injections at home, avoiding the IV infusions previously required for induction.

New antiviral options address gaps in infection care. Hibsago (bepirovirsen) offers selected adults with chronic hepatitis B the possibility of sustained viral control after stopping therapy, a major shift from long-term treatment to suppress the virus. Hovilpri (pritelivir) introduces a new antiviral mechanism and an oral option for immunocompromised adults whose herpes simplex lesions persist despite standard antivirals.

Jemperli (dostarlimab-gxly) offers adults with stage II–III rectal cancer a new treatment option when testing shows their cancer cells cannot properly correct DNA-copying errors. Eligible patients who achieve a complete clinical response may avoid chemotherapy, radiation, and surgery, with close surveillance. Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) bring the first approved immunotherapy regimen to postoperative care for stage III colon cancer with the same DNA repair problem. Added to chemotherapy, they offer a new way to reduce recurrence risk, reinforcing the importance of tumor testing to guide treatment.

Additional Approvals

• Talzenna (talazoparib) plus Xtandi (enzalutamide): Expanded to metastatic hormone-sensitive prostate cancer with mutations in homologous recombination repair genes, identified by an FDA-authorized test.
• Tukysa (tucatinib): Approved with trastuzumab and pertuzumab for maintenance treatment of unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy.
• Jaypirca (pirtobrutinib): Expanded to adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a known chromosome 17p deletion.
• Anktiva (nogapendekin alfa inbakicept-pmln): Expanded use with BCG for BCG-unresponsive non-muscle-invasive bladder cancer to include adults with high-grade papillary-only tumors.
• Rhapsido (remibrutinib): First approved treatment for adults with symptomatic dermographism, or hives triggered by rubbing or scratching, inadequately controlled by H1 antihistamines.
• Enspryng (satralizumab-mwge): Approved for adults with thyroid eye disease, offering the first subcutaneous treatment that patients or caregivers can administer at home.
• Ultomiris (ravulizumab-cwvz): Received accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk for progression.
• Ilumya (tildrakizumab-asmn): Expanded to active psoriatic arthritis in adults, adding another IL-23 inhibitor option administered by a healthcare professional.
• Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd): Received accelerated approval to reduce surgical procedures in adults with recurrent respiratory papillomatosis.
• Ryzumvi (phentolamine mesylate): Eye drops gained a new indication for presbyopia in adults, adding an option for age-related difficulty focusing on nearby objects.
• Lucamzi (ranibizumab-blrz): New biosimilar to Lucentis approved for wet age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
• Isovue (iopamidol): Expanded to oral contrast use during abdominal and pelvic CT in adults and pediatric patients, with a new oral formulation, Isovue Readi, also approved.
• Brytly (apraclonidine hydrochloride): New OTC eye drops approved to relieve redness caused by minor eye irritation.