Upcoming October 2026 FDA regulatory decisions include therapies targeting renal cell carcinoma, colon cancer, small cell lung cancer, thyroid eye disease, presbyopia, chronic hepatitis B, psoriatic arthritis, and recurrent respiratory papillomatosis.
Oncology
Atezolizumab
Roche announced an October 9, 2026, expected FDA decision for the supplemental biologics license application for atezolizumab (Tecentriq) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza), in combination with chemotherapy, for adjuvant treatment of stage III deficient DNA mismatch repair or microsatellite instability-high colon cancer. The FDA accepted the application and granted Priority Review. The application is based on results from the phase 3 ATOMIC trial, in which atezolizumab plus FOLFOX6 chemotherapy reduced the risk of recurrence or mortality by 50% compared with FOLFOX6 alone. At 36 months, disease-free survival was 86% with atezolizumab plus FOLFOX6 and 76% with FOLFOX6 alone.
Source: Roche
Ifinatamab Deruxtecan
Daiichi Sankyo and Merck announced an October 10, 2026, PDUFA action date for the biologics license application for ifinatamab deruxtecan, an investigational B7-H3–directed antibody-drug conjugate, to treat adult patients with extensive-stage small cell lung cancer with disease progression on or following platinum-based chemotherapy. The FDA accepted the application and granted Priority Review. Results from the phase 2 IDeate-Lung01 trial support the application, along with data from the phase 1/2 IDeate-PanTumor01 trial. The FDA previously granted ifinatamab deruxtecan Breakthrough Therapy and Orphan Drug designations for small cell lung cancer.
Source: Merck
Ophthalmology
Satralizumab
Roche announced that an FDA decision is expected by October 15, 2026, on the supplemental biologics license application for satralizumab (Enspryng) to treat thyroid eye disease. The FDA accepted the application and granted Priority Review. The application is based on results from the phase 3 SatraGO-1 and SatraGO-2 trials, which evaluated the efficacy and safety of satralizumab in patients with moderate to severe thyroid eye disease. At week 24, proptosis response rates were 53% with satralizumab and 23% with placebo in SatraGO-2, a statistically significant difference. In SatraGO-1, response rates were 49% with satralizumab and 31% with placebo, but the difference was not statistically significant.
Source: Roche
Phentolamine Ophthalmic Solution
Opus Genetics announced an October 17, 2026, PDUFA goal date for the supplemental new drug application for phentolamine ophthalmic solution 0.75% (Ryzumvi) to treat presbyopia. The FDA accepted the application for review. The application is supported by the phase 3 VEGA-2 and VEGA-3 trials, which met their primary and all key secondary endpoints, with no treatment-related serious adverse events reported. Phentolamine ophthalmic solution 0.75% is currently approved in the US to treat pharmacologically induced mydriasis, while the application under review would add presbyopia to the indication.
Source: Opus Genetics
Gastroenterology
Bepirovirsen
GSK announced an October 26, 2026, PDUFA goal date for the new drug application for bepirovirsen, an investigational antisense oligonucleotide, to treat adults with chronic hepatitis B. The FDA accepted the application, granted Priority Review, and granted bepirovirsen Breakthrough Therapy designation. The application is supported by results from the phase 3 B-Well 1 and B-Well 2 trials, in which bepirovirsen plus standard of care resulted in significantly higher functional cure rates than standard of care alone across all ranked endpoints. The FDA previously granted bepirovirsen Fast Track designation.
Source: GSK
Rheumatology
Tildrakizumab-asmn
Sun Pharma announced that FDA regulatory action is expected by October 29, 2026, for the supplemental biologics license application for tildrakizumab-asmn (Ilumya) to treat adults with active psoriatic arthritis. The FDA accepted the application for review. The application is based on results from the phase 3 INSPIRE-1 and INSPIRE-2 trials, which evaluated the efficacy and safety of tildrakizumab-asmn in adults with active psoriatic arthritis. Tildrakizumab-asmn is currently approved in the US to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Source: Sun Pharma
Otolaryngology
INO-3107
INOVIO announced an October 30, 2026, PDUFA goal date for the biologics license application for INO-3107, an investigational DNA medicine, to treat adults with recurrent respiratory papillomatosis. The FDA accepted the application for Standard Review. In the phase 1/2 RRP-001 trial, 72% of 32 participants had a 50% to 100% decrease in surgeries during the first year following INO-3107 treatment. Among 28 participants included in the retrospective RRP-002 study, 86% had a 50% to 100% decrease in surgeries during the subsequent 12 months without additional treatment. The FDA previously granted INO-3107 Breakthrough Therapy and Orphan Drug designations.
Source: INOVIO
Looking Ahead:
Endocrinology
CagriSema
An FDA decision is expected in the fourth quarter of 2026 on Novo Nordisk's new drug application for CagriSema for weight management. The application, submitted in December 2025, is for an investigational once-weekly therapy combining cagrilintide, a long-acting amylin receptor agonist, with semaglutide, a glucagon-like peptide 1 receptor agonist.
Source: Novo Nordisk
Infectious Disease
Pritelivir
Aicuris announced a fourth-quarter 2026 PDUFA target date for the new drug application for pritelivir to treat refractory herpes simplex virus infection, with or without resistance, in immunocompromised patients. The FDA granted the application Priority Review. The application is supported by results from the phase 3 PRIOH-1 trial, in which pritelivir met the primary endpoint, with significantly greater lesion healing after up to 28 days of treatment compared with investigator’s choice therapy, and had a favorable safety profile. The FDA previously granted pritelivir Breakthrough Therapy designation.
Source: Aicuris