FDA issues guidance on implementing decentralized elements in clinical trials

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

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

Drugs & Targets

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).

March 21, 2025

Vol.51 No.11

FDA issues guidance on implementing decentralized elements in clinical trials

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

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

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

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FDA issues guidance on implementing decentralized elements in clinical trials

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

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

FDA approves Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

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 Keytruda combination for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)