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May 11, 2026
On May 5, the FDA quietly released a new guidance document with considerations regarding its existing policy flexibilities for chemistry, manufacturing and controls issues in cell and gene therapy products. Here, AgencyIQ breaks down what’s in that document and the discussion of it at a timely May 6 Friends of Cancer Research workshop. Catching up:…
Read MoreMay 11, 2026
Sponsors working outside the US to accelerate first-in-human studies could miss the many new flexibilities the US FDA offers, the agency’s head of cell and gene therapy application reviews said. Key Takeaways Acting OTP Director Vijay Kumar said that overseas first-in-human studies may not provide a long-term benefit. He said sponsors would forego the advantages…
Read MoreMay 10, 2026
Listen to Dr. Crystal Mackall on the Future of Medicine podcast — a fascinating conversation about the science, breakthroughs, and challenges shaping the next era of cancer treatment. Dr. Crystal Mackall, a pioneer in cancer immunotherapy, traces her journey from a working-class Ohio upbringing to leading cutting-edge T-cell research at Stanford. Inspired by family members…
Read MoreMay 8, 2026
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs). The document marks the third cell and gene therapy guidance released by the agency in 2026 following…
Read MoreMay 7, 2026
Patient advocates and other stakeholders are urging FDA to make predictability and consistency the center of the agency’s rare disease approach after controversies over unexpected product rejections under now-former biologics center director Vinay Prasad, saying new leadership at the center needs to address concerns from patient advocates that recent decisions have been arbitrary or politically…
Read MoreMay 6, 2026
Embattled FDA Commissioner Marty Makary is testifying before the Senate Appropriations Committee next Wednesday (May 13), where he’s likely to face questions about how drug approval processes have been impacted by FDA’s leadership turnover, decline in staffing levels and controversial Commissioner’s National Priority Review Voucher program. FDA stakeholders are questioning whether Makary will keep his…
Read MoreMay 5, 2026
The FDA’s Oncologic Drugs Advisory Committee voted 6-3 against the demonstrated benefit of AstraZeneca’s camizestrant, proposed to extend the duration of first-line therapy for a subset of metastatic breast cancer patients. The trial leveraged circulating tumor DNA technology to identify an emerging, resistance-associated mutation and trigger a treatment change – a paradigm shift that the…
Read MoreMay 4, 2026
Editor’s note: This article was updated on 7 May 2026 to correct the name of one of the organizations that commented on the guidance. The US pharmaceutical industry expressed support for the US Food and Drug Administration’s (FDA) proposed framework for increasing access to treatments for ultra-rare diseases yet raised questions concerning various aspects of…
Read MoreMay 1, 2026
Lung-MAP, a precision medicine umbrella trial for patients with advanced non-small cell lung cancer (NSCLC), has expanded genetic screening options for patients who enroll in this clinical trial of biomarker-driven therapies. The Friends of Cancer Research (Friends) hosted a webinar to explore how Lung-MAP is accelerating lung cancer discovery. “Lung-MAP has always stood out for…
Read MoreApril 17, 2026
A meeting convened by Friends of Cancer Research focused on the methodology for using external control arms in cancer clinical trials. At the April 7 meeting, titled “Application of External Control Arms in Oncology Drug Development,” leaders across government, academia, industry, and patient advocacy examined the evolving role of external control arms, or ECAs, in…
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