FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

FDA announced the final design of the Expedited Investigational New Drug Pilot.

September 18, 2026

FDA approves imlunestrant + abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

September 18, 2026

Vol.52 No.34

Drugs & Targets

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

FDA has granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

September 18, 2026

Vol.52 No.34

Podcast

9/11, mRNA, musical chairs—and an assassination attempt

This week’s oncology headlines run the gamut—from a discussion on the long-term consequences of 9/11 on lung cancer incidence, to the promise—and limits—of cutting edge mRNA science, to major institutional leadership changes, and even the intersection of cancer and war.

September 16, 2026

Cancer Policy

Heidi Overton selected as FDA commissioner; Jared Seehafer named inaugural Deputy Commissioner for Technology and AI

As part of a sweep of leadership changes at FDA, Heidi Overton, deputy director of the White House Domestic Policy Council, has been nominated to the role of FDA commissioner.

September 11, 2026

Vol.52 No.33

By Claire Marie Porter

Drugs & Targets

FDA grants accelerated approval to iberdomide combination for MM

FDA granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

September 11, 2026

Vol.52 No.33

FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

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FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

FDA approves imlunestrant + abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

9/11, mRNA, musical chairs—and an assassination attempt

Heidi Overton selected as FDA commissioner; Jared Seehafer named inaugural Deputy Commissioner for Technology and AI

FDA grants accelerated approval to iberdomide combination for MM

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