FDA approvals lead a busy week of agency actions

FDA approvals numbered five in the actions published so far in the week of October 19 to 25, 2026. The Priority Review, which compiled the week from agency records, counted 10 actions in total: 5 approval announcements, 2 proposed rules in the Federal Register, 2 notices in the Federal Register and 1 press announcement. The week ends on Sunday, October 25, 2026, and the page notes that it updates as further records arrive.

The FDA approvals list opened with dostarlimab on October 19. Each approval rests on its own trial or application record, and the list below follows the agency records as compiled. The approvals do not share a single disease area, which is normal for a weekly agency tally that groups separate decisions by date rather than by theme.

On October 19, 2026, the FDA granted accelerated approval to dostarlimab, sold as Jemperli by GSK, the first of the week, for adults with stage II or III locally advanced rectal cancer that is microsatellite instability high or mismatch repair deficient. The approval was based on AZUR-1, a single arm trial of 154 patients that reported a 47 percent sustained clinical complete response at 12 months per independent central review.

FDA approvals in cancer care

On October 20, 2026, the FDA approvals included the first generic of Climara Pro, a transdermal estradiol and levonorgestrel system applied once a week for women with an intact uterus. The dose is 0.045 mg per day of estradiol and 0.015 mg of levonorgestrel. The generic is therapeutically equivalent to Climara Pro. The most common adverse reactions listed were application site reaction, vaginal bleeding and breast pain, each in at least 5 percent of patients.

The same day, the FDA approved Hibsago, the brand name for bepirovirsen injection, as a first of its kind chronic hepatitis B treatment. The approval covers adults without cirrhosis who have been on antiviral therapy for at least six months and have hepatitis B surface antigen levels of 3,000 IU per mL or less. The approval includes the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic. That hepatitis B treatment includes the test to help identify patients who fit the approved use.

On October 22, 2026, the FDA granted traditional approval to pembrolizumab, sold as Keytruda, and to Keytruda QLEX, which pairs pembrolizumab with berahyaluronidase alfa-pmh, for patients with unresectable or metastatic tumour mutational burden high solid tumours defined as at least 13 mutations per megabase. In the KEYNOTE-158 study, 220 patients with that level had an objective response rate of 36 percent, and 58 percent achieved a duration of response of at least 12 months.

FDA approvals for paediatric diabetes

On October 23, 2026, the FDA approved Awiqli, the brand name for insulin icodec-abae, as the first once weekly insulin for type 2 diabetes in paediatric patients. The approval covers children aged 10 years and older with type 2 diabetes mellitus. Awiqli is the first once weekly insulin option in this paediatric group, according to the approval record. The drug is given by subcutaneous injection once weekly and was approved after a priority review. Priority review shortens the agency review period, but it does not change the evidence standard for approval.

Alongside the FDA approvals, the proposed rules in the week were both dated October 23, 2026. One was a draft guidance on action levels for cadmium in processed food intended for babies and young children under 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supply. The other was a new draft chapter, Chapter 12 on control of chemical hazards, as part of multichapter draft guidance on hazard analysis and risk based preventive controls for human food. That guidance is not final and is not yet in effect.

FDA approvals and other agency notices

Alongside the FDA approvals, two notices were dated in the same week: final guidance on new dietary ingredient notifications, and corrections to the regulatory review period for six drugs due to calculation errors.

The press announcement was final guidance issued October 20, 2026, on prescription drug apps and software. The guidance clarifies when app content is subject to FDA submission requirements and when it should be mentioned on a drug label. Taken together, the FDA approvals and the other 5 actions show a week split between new treatments and the routine work of guidance, corrections and food safety drafts.