FDA approves Lumisight to assist breast cancer detection

In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

Credit: NCI/Linda BartlettIn an oral history conducted by FDA in September 2013, Andrew C. von Eschenbach recounted his eight-month stint in a dual role as both FDA acting commissioner and NCI director.

FDA approves durvalumab for muscle invasive bladder cancer

FDA approved AstraZeneca’s durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer.

April 04, 2025

Vol.51 No.13

Drugs & Targets

Exact Sciences launches the Cologuard Plus test for colorectal cancer screening

Exact Sciences Corp. announced the launch of Cologuard Plus, the most accurate noninvasive colorectal cancer screening test reported in studies to date. FDA-approved for average-risk patients 45+ and covered by Medicare, the Cologuard Plus test detects 95% of colorectal cancers at 94% specificity in the U.S. screening population.

April 04, 2025

Vol.51 No.13

Capitol Hill

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

The U.S. Department of Health and Human Services announced that it is making sweeping revisions by cutting personnel, centralizing functions, and consolidating divisions.

March 28, 2025

Vol.51 No.12

By Claire Marie Porter and Jacquelyn Cobb

Drugs & Targets

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approved cabozantinib (Cabometyx) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.

March 28, 2025

Vol.51 No.12

Drugs & Targets

FDA approves prostate cancer imaging agent Gozellix

FDA approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), a next-generation PSMA-PET imaging agent for prostate cancer.

March 28, 2025

Vol.51 No.12

FDA approves Lumisight to assist breast cancer detection

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In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

FDA approves durvalumab for muscle invasive bladder cancer

Exact Sciences launches the Cologuard Plus test for colorectal cancer screening

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approves prostate cancer imaging agent Gozellix

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FDA approves Lumisight to assist breast cancer detection

YOU MAY BE INTERESTED IN

In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

FDA approves durvalumab for muscle invasive bladder cancer

Exact Sciences launches the Cologuard Plus test for colorectal cancer screening

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hitAlso this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approves prostate cancer imaging agent Gozellix

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology