In The News

July 29, 2026

Applied Clinical Trials — FDA Finalizes Three Guidances to Broaden Cancer Clinical Trial Eligibility

New documents targeting performance status, washout periods, and laboratory value thresholds aim to close the gap between patients willing to participate in oncology trials and those who actually enroll. The FDA’s Oncology Center of Excellence (OCE) has issued three final guidance documents intended to expand eligibility criteria for participation in oncology clinical trials, targeting a…

July 28, 2026

AgencyIQ — FDA finalizes guidances on cancer trial eligibility criteria

The FDA changed relatively little in finalizing three guidance documents that contain recommendations for constructing cancer trial eligibility criteria involving laboratory values, concomitant treatment and performance status. The concepts they explain may also apply to other clinical areas. Clinical trial representation: A quick background The FDA requires substantial evidence of a drug or biologic product’s…

July 28, 2026

POLITICO — FDA panel to consider previously spurned drugs

A RARE REDO — An FDA advisory committee will hold two days of meetings this week to review applications for novel therapies disfavored by political appointees who have since left the agency. The Cellular, Tissue and Gene Therapy Advisory Committee will review Capricor’s deramiocel to treat heart issues in Duchenne muscular dystrophy patients on Wednesday. Thursday…

July 28, 2026

The ASCO Post — FDA Releases Final Guidances to Expand Participation in Cancer Clinical Trials

The FDA’s Oncology Center of Excellence announced three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs. Fewer than 5% of patients with cancer currently receiving treatment are enrolled in clinical trials—even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation: stringent…

July 27, 2026

RAPS: Regulatory Focus — FDA finalizes three guidances to broaden cancer clinical trial eligibility

The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods. Fewer than 5% of cancer patients currently undergoing treatment are enrolled in…

July 27, 2026

Pink Sheet — Beyond Operation TrialBlazer: Congress Sounds Ready To Act On IND Pathways

Legislators appears eager to build on the US Food and Drug Administration’s plans to expedite IND reviews in the upcoming user fee reauthorization cycle. During a July 15 hearing on the FDA’s role in maintaining US leadership in biomedical innovation, House Energy and Commerce Health Subcommittee Chair Morgan Griffith, R-VA, discussed the importance of reforms to the…

July 27, 2026

Pink Sheet — New Cancer Clinical Trial Guidances Continue US FDA Push For Expanded Eligibility

New guidances on cancer clinical trial eligibility continue pushing the US Food and Drug Administration opinion that overly restrictive criteria often are not necessary and can hinder drug development. The three final guidances released July 27 are aimed at cancer clinical trials, but the agency said the recommendations could impact drug development in other diseases.…

July 27, 2026

American Pharmaceutical Review — FDA Releases Final Guidances to Expand Participation in Cancer Clinical Trials

The FDA’s Oncology Center of Excellence is announcing three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs. Fewer than 5% of cancer patients currently receiving treatment are enrolled in clinical trials even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation…

July 24, 2026

Oncology Nursing Society (ONS) — This Week’s Advocacy News: ‘New Analysis Shows China Has Outpaced the United States in Novel Cancer Drug Approvals Since 2023’

ONS Perspective China’s increasing number of oncology drug approvals is a result of growing international advancements to end cancer as we know it. However, although China approved 94 oncology drugs from 2023–2025, compared with the United States’ 87 approvals, Friends of Cancer Research also found that “among the 14 drugs approved by both agencies, the…

July 24, 2026

The Cancer Letter — China has outpaced the U.S. in novel cancer drug approvals since 2023, Friends analysis shows

China approved more novel oncology drugs than the United States from 2020 to 2025, according to a new analysis from Friends of Cancer Research  published in Health Affairs Scholar. During the six-year study period, FDA approved 87 novel oncology drugs, compared with 94 approved by China’s National Medical Products Administration, or the NMPA. The NMPA’s approval volume…

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