FDA grants clearance for radiation oncology tool to calculate absorbed dose of radionuclides

Katherine Szarama steps in as CBER acting director, replacing Prasad

Following Vinay Prasad’s second and presumably final departure from his job as director of the Center for Biologics Evaluation and Research, Prasad’s deputy Katherine Szarama has stepped in as acting drector.

May 08, 2026

By Claire Marie Porter

Funding Opportunities

FDA’s OCE announces funding opportunity in ultra-rare cancers

The FDA Oncology Center of Excellence (OCE) has announced a Request for Applications to support U01 cooperative agreements for Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers.

May 08, 2026

Drugs & Targets

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA has issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol for its experimental pancreatic cancer drug, daraxonrasib, a RAS inhibitor.

May 08, 2026

By Claire Marie Porter

Drugs & Targets

FDA approves Jakafi XR tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease

FDA has approved Jakafi XR (ruxolitinib) extended-release tablets for the treatment of adults with intermediateor high-risk myelofibrosis; adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease or chronic GVHD after failure of one or two lines of systemic therapy.

May 08, 2026

Podcast

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

The Cancer Letter’s coverage of HHS-led overhauls of foundational scientific institutions continued last week with two unrelated stories pointing to continued disarray amongst public health leadership.

May 06, 2026

Regulatory News

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

Disappointment hangs in the air as Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab in the treatment of advanced melanoma was denied again by FDA on April 10.

May 01, 2026

Vol.52 No.17

By Sara Willa Ernst

FDA grants clearance for radiation oncology tool to calculate absorbed dose of radionuclides

YOU MAY BE INTERESTED IN

Katherine Szarama steps in as CBER acting director, replacing Prasad

FDA’s OCE announces funding opportunity in ultra-rare cancers

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA approves Jakafi XR tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

Renew today!

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FDA grants clearance for radiation oncology tool to calculate absorbed dose of radionuclides

YOU MAY BE INTERESTED IN

Katherine Szarama steps in as CBER acting director, replacing Prasad

FDA’s OCE announces funding opportunity in ultra-rare cancers

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA approves Jakafi XR tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients“Patients are owed another review.”

Never miss an issue!

Login

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”