New data show more than 2.5M U.S. youth use e-cigarettes

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 History Project

25 years after 9/11, a smoking cessation program may have curbed lung cancer risk for first responders at Ground Zero
“We seem to have a risk of exposure that needed that extra boost of the cigarette to cause the cancer.”

Twenty-five years ago, the attack on the World Trade Center engulfed Ground Zero in a shroud of smoke, leaving Lower Manhattan covered in toxic dust for months.

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

New data show more than 2.5M U.S. youth use e-cigarettes

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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

25 years after 9/11, a smoking cessation program may have curbed lung cancer risk for first responders at Ground Zero
“We seem to have a risk of exposure that needed that extra boost of the cigarette to cause the cancer.”

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

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New data show more than 2.5M U.S. youth use e-cigarettes

YOU MAY BE INTERESTED IN

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

25 years after 9/11, a smoking cessation program may have curbed lung cancer risk for first responders at Ground Zero“We seem to have a risk of exposure that needed that extra boost of the cigarette to cause the cancer.”

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

Never miss an issue!

Login

25 years after 9/11, a smoking cessation program may have curbed lung cancer risk for first responders at Ground Zero
“We seem to have a risk of exposure that needed that extra boost of the cigarette to cause the cancer.”