Imagine running a finger across your arm and watching a raised, itchy welt appear where it passed. People with symptomatic dermographism live with that, often called “skin writing,” and until October 7 nothing was approved specifically for them when antihistamines fell short.
That changed with remibrutinib, sold as Rhapsido by Novartis. In the phase 3 RemIND trial, 29.35% of patients on the drug had a complete response from hives at week 12, against 14.0% on placebo. Some saw results by week 2. “For the first time,” said lead investigator Giselle Mosnaim, MD, of the University of Chicago Pritzker School of Medicine, the drug gives these patients an approach built for them, “a meaningful step forward.” Side effects included nasal congestion, sore throat, runny nose, bleeding, headache, nausea and abdominal pain.
Five approvals beyond cancer
It was one of five non-oncology approvals the FDA announced in October, spread across allergy, psychiatry, ophthalmology, hepatology and gastroenterology. Several share a theme that matters to families: treatment that happens at home, not in a clinic chair.
Two days after the hives decision, the agency approved Weltruza, an olanzapine injection from Teva for adults with schizophrenia. It is given under the skin once a month, in doses of 318, 425 or 531 mg, with no loading doses, no pills on the side and no monitoring after the shot. In the SOLARIS trial, 675 patients in an acute episode were randomized to one of three doses or placebo. All three doses beat placebo on the PANSS total score by week 8. Weight gain, headache, constipation and injection-site reactions were the common complaints.
On October 15 came satralizumab, sold as Enspryng by Genentech, for thyroid eye disease, the first treatment of its kind that patients can inject at home. In the SatraGO-2 trial, 52.9% of people with active disease had a meaningful drop in eye bulging, versus 23.4% on placebo, and 60.7% saw less double vision, versus 25.8%. SatraGO-1 did not reach its main goal, which is worth knowing. César A. Briceño, MD, of the Scheie Eye Institute, said a subcutaneous option could ease “the logistical burden associated with infusion-based therapies.”
A possible cure for hepatitis B
The boldest claim belongs to bepirovirsen, which GSK markets as Hibsago. Approved October 20, it is meant for adults with chronic hepatitis B who have no cirrhosis, have taken antivirals for at least 6 months, and have surface antigen levels of 3000 IU/mL or less. Two phase 3 trials, B-Well 1 and B-Well 2, showed significantly better functional cure rates than placebo. Mark Makhinson, PharmD, of Mount Sinai Health System, told The American Journal of Managed Care it could be “the first cure in the space instead of a lifelong treatment.”
Then, on October 23, AbbVie’s Skyrizi won approval for a home induction regimen in moderate to severe Crohn disease. Patients wear an on-body injector instead of travelling to an infusion center. In the AFFIRM trial of 274 adults, 56% reached clinical remission at week 12 versus 30% on placebo, and 43% had an endoscopic response versus 15%.
A DNA drug, 20 years in the making
October 30 brought a different kind of milestone. Voceryq, from Inovio, received accelerated approval for recurrent respiratory papillomatosis, a rare HPV-driven disease that grows wart-like tissue in the airway. It is Inovio’s first approved product after more than two decades in DNA medicine. The treatment pairs two plasmids, one carrying HPV-6 and HPV-11 antigens and the other the immune signal IL-12, and is delivered into muscle with an electroporation device.
The evidence is thin. In an open-label trial of 32 adults, 27% of those with a heavier surgical history needed no surgery in the year after treatment. Before dosing, participants had a median of 4 operations a year, ranging from 2 to 8. Because the approval rests on an intermediate endpoint, Inovio must run follow-up trials to confirm the benefit.
A drug under threat
Not every FDA story this autumn was good news. The agency has proposed pulling Tavneos, approved in 2021 for ANCA-associated vasculitis, citing severe and sometimes fatal liver injuries. It also says ChemoCentryx staff picked certain patients for reassessment after the trial was unblinded. Tracy Beth Høeg, acting director of the FDA’s drug center, linked the drug to eight deaths and dozens of hospitalizations. The drug is already off the market in the European Union. Amgen, which paid nearly $4 billion for ChemoCentryx, disputes the findings in a 104-page filing, and the FDA must offer a public hearing before any final withdrawal.
Sources
- October FDA Approvals Bring Advances Across 5 Specialties | AJMC
- October 2026 FDA Approvals: 7 Cancer Updates for Oncology Nurses | Oncology Nursing News
- FDA Roundup: Oncology Approvals, Submissions, and Designations in October 2026 | Targeted Onc – Immunotherapy, Biomarkers, and Cancer Pathways
- OT Roundup: 3 FDA approvals, vorolanib insert miss, brepocitinib in uveitis | Eye Care Network – Ophthalmology Times
- Inovio Stock After Voceryq Approval: A Regulatory Win Walks Into a Commercial Fight
- FDA proposes withdrawing Tavneos approval in the US
Photo: Ortopediatri Çocuk Ortopedi Akademisi / Unsplash (Unsplash License)
