Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

The Friends of Cancer Research annual meeting, to be held Nov. 4 in Washington, DC, will focus on three questions facing the field of oncology clinical trial design.

NEJM, public health group to launch alternate publication to CDC’s MMWR

Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, often called “the voice of the CDC,” now has an rival publication.

October 31, 2025

Vol.51 No.40

By Claire Marie Porter

Drugs & Targets

FDA publishes draft guidance to accelerate biosimilar development and lower costs

In a new draft guidance, FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.

October 31, 2025

Vol.51 No.40

Cancer Policy

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).

October 24, 2025

Vol.51 No.39

By Claire Marie Porter

Drugs & Targets

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

FDA approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

October 24, 2025

Vol.51 No.39

Drugs & Targets

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

October 24, 2025

Vol.51 No.39

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

YOU MAY BE INTERESTED IN

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

NEJM, public health group to launch alternate publication to CDC’s MMWR

FDA publishes draft guidance to accelerate biosimilar development and lower costs

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

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Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

YOU MAY BE INTERESTED IN

Friends publishes three white papers ahead of annual meetingTopics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

NEJM, public health group to launch alternate publication to CDC’s MMWR

FDA publishes draft guidance to accelerate biosimilar development and lower costs

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Never miss an issue!

Login

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies