FDA grants Breakthrough Therapy Designation to epcoritamab-bysp

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

UT Austin study uncovers new driver of immunotherapy resistance in pancreatic cancer

Pancreatic tumors can resist immunotherapy by recruiting nearby immune cells to help protect them, according to researchers at The University of Texas at Austin. The findings, published in Nature Communications, also point to a potential new strategy for overcoming resistance and improving cellular therapies.

September 18, 2026

Vol.52 No.34

Clinical Roundup

Salk institue team discovers novel pathway, provides insights to combat immunotherapy resistance

Why do signaling proteins called interferons, which recruit the immune system to attack cancer cells, start helping the tumor grow rather than shrink when they linger too long?

September 18, 2026

Vol.52 No.34

Drugs & Targets

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 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

FDA grants Breakthrough Therapy Designation to epcoritamab-bysp

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

UT Austin study uncovers new driver of immunotherapy resistance in pancreatic cancer

Salk institue team discovers novel pathway, provides insights to combat immunotherapy resistance

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

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

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