ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

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

CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the EU for the treatment of adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.

April 04, 2025

Vol.51 No.13

Drugs & Targets

CHMP recommends approval for Tevimbra as a first-line treatment for extensive-stage small cell lung cancer

BeiGene Ltd. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung 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

In Brief

Karen Knudsen joins Paradigm Health’s board of directors as company prepares launch of AI-driven clinical trial data collection and management application

Paradigm Health announced on March 20 the appointment of Karen E. Knudsen to its board of directors, alongside the upcoming launch of its eSource clinical trial data application.

March 28, 2025

Vol.51 No.12

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

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

CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

CHMP recommends approval for Tevimbra as a first-line treatment for extensive-stage small cell lung 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

Karen Knudsen joins Paradigm Health’s board of directors as company prepares launch of AI-driven clinical trial data collection and management application

Never miss an issue!

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

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

CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

CHMP recommends approval for Tevimbra as a first-line treatment for extensive-stage small cell lung 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

Karen Knudsen joins Paradigm Health’s board of directors as company prepares launch of AI-driven clinical trial data collection and management application

Never miss an issue!

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