Platinum drugs are off the shortage list, but the underlying problem is unsolved FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Vol.51 No.20

Regulatory News

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

FDA Commissioner Makary holds roundtable discussion on harms of talc

FDA Commissioner Marty Makary held a roundtable of independent scientific experts to discuss the safety and necessity of talc as an additive to food, drugs, and cosmetic products.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter

Cancer Policy

Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

FDA—under the leadership of cyber-iconoclast and new director of the agency’s Center for Biologics Evaluation and Research, Vinay Prasad—is taking a new approach to COVID-19 vaccines.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter

Funding Opportunities

Call for applications: Investigator-Initiated Health Care Research Grant Program

The National Institute for Health Care Management Foundation is now accepting letters of inquiry for the 2025-2026 funding cycle of NIHCM Foundation’s Research Grant program. We will be awarding a total of $500,000 in grants to support innovative, independent, investigator-initiated research that has the potential to inform managed care organizations, policymakers, and related stakeholders to improve the affordability and quality of U.S. health care.

May 23, 2025

Vol.51 No.20

Drugs & Targets

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

FDA has approved Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who received prior systemic therapy. Avmapki Fakzynja Co-Pack is the first and only FDA-approved medicine for this disease.

May 23, 2025

Vol.51 No.20

Platinum drugs are off the shortage list, but the underlying problem is unsolved

FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

YOU MAY BE INTERESTED IN

In The Headlines: Back to “business as usual” at FDA?

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

FDA Commissioner Makary holds roundtable discussion on harms of talc

Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access

Call for applications: Investigator-Initiated Health Care Research Grant Program

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

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