FDA approves Udenyca autoinjector

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

Earlier this week, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), for adults with previously untreated stage 2 or stage 3 rectal cancer that is mismatch repair deficient or microsatellite instability-high, marking a celebratory moment for the field.

FDA expands approval of Talzenna + Xtandi for an earlier metastatic prostate cancer treatment setting

FDA has expanded approval of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, including both BRCA and non-BRCA mutations.

October 30, 2026

Vol.52 No.40

Drugs & Targets

FDA releases guidance for sponsors developing gene therapies for rare diseases

FDA is accepting comments on a new regulatory framework that it published for industry sponsors developing personalized gene therapies to treat rare diseases.

FDA authorizes marketing of 24 nicotine pouches

FDA authorized the marketing of 24 nicotine pouch products through the premarket tobacco product application pathway. The authorized products are made by Modoral Brands Inc. under the Velo brand and are all listed as containing 4 mg of nicotine.

October 30, 2026

Vol.52 No.40

In Brief

Jessica Zeller named director of the Office of Compliance and Enforcement, FDA Center for Tobacco Products

Jessica Zeller was named director of the Office of Compliance and Enforcement at the FDA Center for Tobacco Products.

October 23, 2026

Vol.52 No.39

Drugs & Targets

FDA approves pembro or pembro + berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

FDA has granted a traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [≥13 mutations/megabase] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

October 23, 2026

Vol.52 No.39

FDA approves Udenyca autoinjector

YOU MAY BE INTERESTED IN

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

FDA expands approval of Talzenna + Xtandi for an earlier metastatic prostate cancer treatment setting

FDA releases guidance for sponsors developing gene therapies for rare diseases

FDA authorizes marketing of 24 nicotine pouches

Jessica Zeller named director of the Office of Compliance and Enforcement, FDA Center for Tobacco Products

FDA approves pembro or pembro + berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication

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