Panel submits operational evaluation of FDA’s tobacco program

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

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

Cancer Policy

FDA authorizes second e-cigarette with age-gating features

FDA cleared the JUUL2 e-cigarette in tobacco and menthol flavors. This is the second vaping device the agency has authorized that incorporates age-gating technology—features intended to block access to minors and to keep e-cigarettes out of the hands of never-smokers at a vulnerable age.

September 11, 2026

Vol.52 No.33

By Sara Willa Ernst

Panel submits operational evaluation of FDA’s tobacco program

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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

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

FDA authorizes second e-cigarette with age-gating features

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Panel submits operational evaluation of FDA’s tobacco program

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

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

FDA authorizes second e-cigarette with age-gating features

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.”