FDA actions, week of October 19, 2026: 3 approvals, 1 notice, 1 announcement
The FDA published 5 actions so far in the week of October 19 to 25, 2026: 3 approval announcements, 1 notice in the Federal Register and 1 press announcement.
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Each line below links the stream brief and the agency's own record, grouped by the type of record.
This page updates as the week's records arrive. The week ends on Sunday, October 25, 2026.
Approvals
- FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer. On October 19, 2026 the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/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% sustained clinical complete response at 12 months per independent central review. Source: FDA approval page, October 19, 2026.
- FDA approves once-weekly generic hormone therapy patch for women. The FDA approved the first generic of Climara Pro, a transdermal estradiol and levonorgestrel system (0.045 mg per day/0.015 mg) applied once a week for women with an intact uterus. The generic is therapeutically equivalent to Climara Pro and the most common adverse reactions are application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome (≥5 %). Source: FDA press announcement, October 20, 2026.
- FDA approves first-of-its-kind chronic hepatitis B treatment. The FDA approved Hibsago (bepirovirsen) injection for adults without cirrhosis who have been on antiviral therapy for at least six months and have HBsAg levels of 3,000 IU/mL or less. The approval includes the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic. Source: FDA press announcement, October 20, 2026.
Notices
- FDA releases guidance on new dietary ingredient notifications. The Food and Drug Administration announced the availability of final guidance titled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry." The guidance addresses frequently asked questions and provides recommendations for manufacturers and distributors on the identity and safety information that should be included in an NDIN. Source: Federal Register notice, October 20, 2026.
Other announcements
- FDA issues final guidance on prescription drug apps and software. The FDA released final guidance on October 20, 2026 that clarifies when app content is subject to FDA submission requirements and when it should be mentioned on a drug's official label. The guidance identifies two categories of companion software-apps connected to a medical device and standalone apps-and sets conditions for labeling and what companies should submit to the agency. Source: FDA press announcement, October 20, 2026.
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