FDA clears first HPV self-collection kit and assay for at-home use, marking a step toward improving screening uptake

FDA launches Rare Disease Framework Initiative for drug development

FDA announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.

October 16, 2026

Vol.52 No.38

Cancer Policy

FDA seeks nominations for the Tobacco Products Scientific Advisory Committee, announces new members

FDA is requesting nominations by Dec. 14 for voting members to serve on the Tobacco Products Scientific Advisory Committee.

October 16, 2026

Vol.52 No.38

Drugs & Targets

FDA approves atezolizumab + chemotherapy for stage 3 colon cancer

FDA approved the immunotherapy drug atezolizumab in combination with chemotherapy for some patients with stage 3 colon cancer following surgery. The treatment is for patients whose tumors have deficient DNA mismatch repair.

October 16, 2026

Vol.52 No.38

Drugs & Targets

FDA expands Anktiva approval for BCG-unresponsive non-muscle-invasive bladder cancer to cover both papillary and CIS disease

FDA expanded the approved indication for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin to include patients with BCG-unresponsive NMIBC with papillary-only tumors.

October 16, 2026

Vol.52 No.38

Podcast

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

As the oncology community waits with bated breath for a possible FDA approval of GRAIL’s Galleri test, NCI Director Anthony Letai has a lot to say about multi-cancer detection tests—particularly Galleri.

October 14, 2026

Drugs & Targets

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

FDA approved Tuksya (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. The approval expands the use of Tuksya to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

October 09, 2026

Vol.52 No.37

FDA clears first HPV self-collection kit and assay for at-home use, marking a step toward improving screening uptake

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FDA launches Rare Disease Framework Initiative for drug development

FDA seeks nominations for the Tobacco Products Scientific Advisory Committee, announces new members

FDA approves atezolizumab + chemotherapy for stage 3 colon cancer

FDA expands Anktiva approval for BCG-unresponsive non-muscle-invasive bladder cancer to cover both papillary and CIS disease

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

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