The FDA’s 2026 approvals list has reached 47 drugs, including a first for metastatic pancreatic cancer

The 47th entry on the FDA’s list of novel drug approvals for 2026 is Hibsago, a hepatitis B treatment from GSK approved on October 20. The list, which the agency stamps as current through that date, now holds 47 drugs in total, and the 34th of them, in August, was a first-class targeted therapy for metastatic pancreatic cancer, in the FDA’s own words.

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The list counts novel drugs only, a narrower set than every drug approval in a year, and the pace this autumn has been steady: five entries landed between September 25 and October 20 alone.

Number 47: Hibsago and a six-month course for hepatitis B

The FDA’s Novel Drug Approvals for 2026 page lists Hibsago (bepirovirsen) as number 47, approved 10/20/2026 to treat chronic hepatitis B virus infection in certain adults without cirrhosis. The three entries before it were Hovilpri (pritelivir) on October 9 for herpes simplex lesions in immunocompromised adults, Emcitate (tiratricol) on September 28 for peripheral thyrotoxicosis in MCT8 deficiency, and Atebrioz (zilurgisertib) on September 25 for heterotopic ossification in fibrodysplasia ossificans progressiva.

GSK’s approval announcement sets out the eligibility. Patients must have taken nucleos(t)ide analogue therapy for at least six months, have suppressed HBV DNA, and have HBsAg levels of 3000 IU/ml or below on an FDA-authorised test. In the pooled B-Well 1 and B-Well 2 phase III trials, run in 29 countries, functional cure came in 19 percent of treated patients in that population (233 of 1,220) against none of 614 on placebo, and 26 percent (200 of 768, against 0 of 393) among those with HBsAg at or under 1000 IU/ml. The company says standard care alone typically yields under 1 percent functional cure after a year.

Tony Wood, GSK’s chief scientific officer, said that for the first time, with Hibsago, U.S. patients have the potential to achieve a functional cure after a six-month treatment course. Priority review and Breakthrough Therapy designation applied, and the most frequent adverse events were injection site redness, local pain and a temporary rise in a liver enzyme.

Efficacy continued into the exploratory analyses. At week 72, HBsAg fell to 100 IU/ml or below in 49 percent of the overall treated group and 62 percent of the 1000 IU/ml-or-lower subgroup, GSK reported. Treatment is a six-month course with the option of self-administration after the first dose, and bepirovirsen, licensed from Ionis Pharmaceuticals, is also approved in Japan. Norah Terrault of USC Keck Medical Center called the approval the start of a new era in chronic hepatitis B treatment, according to the release, and Chari Cohen of the Hepatitis B Foundation pointed to progress in screening, diagnosis and treatment options.

Number 34: the pancreatic cancer entry

Rasonque (daraxonrasib), from Revolution Medicines, appears on the same list as number 34, approved 8/26/2026 for metastatic pancreatic cancer. In its own announcement, the FDA called it a first-class targeted therapy, a once-daily tablet aimed at multiple forms of the RAS protein that drives tumor growth in most pancreatic adenocarcinomas. The trade press describes it as the first approved RAS(ON) multi-selective and mutant-selective inhibitor.

The indication is adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy, according to the FDA approval notice, which identifies the pivotal RASolute 302 trial (NCT06625320). In 500 adults with previously treated disease, median overall survival was 13.2 months on Rasonque against 6.7 months on standard chemotherapy. The common side effects were rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.

Acting FDA Commissioner Kyle Diamantas called the approval “a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.” Angelo de Claro, director of the agency’s Oncology Center of Excellence, said the drug “showed unprecedented results in an area of high unmet need.” The FDA cited National Cancer Institute figures of about 67,000 new pancreatic cancer cases a year in the United States, roughly 90 to 95 percent of them adenocarcinoma. The agency also reported Breakthrough Therapy and Orphan Drug designations, Priority Review, and an approval 6.5 months ahead of the user fee deadline under the Commissioner’s National Priority Voucher pilot, after a May “safe to proceed” letter that allowed an expanded access protocol before approval.

Reading the list as a ledger

A tally of 47 by October 20 means the year’s average has run close to five novel approvals a month, though the entries are lumpy: three arrived on May 29 alone, and two on September 25. The list also spans very different jobs, from imaging agents such as Pixclara (floretyrosine F 18) and Tauklarify (florquinitau F 18) to a weight-reduction drug, Foundayo (orforglipron), approved April 1, and a first entry for Menkes disease in January.

Whether the count climbs past 47 before year-end depends on decisions the page does not yet show. The currency stamp reads 10/20/2026, and the FDA updates the table as each approval is added.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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