Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop May 18, 2026

https://www.fda.gov/drugs/news-events-human-drugs/advancing-novel-surrogate-endpoints-rare-disease-drug-development-workshop-05182026?utm_medium=email&utm_source=govdelivery Reminder: FDA to Hold Workshop on Advancing Novel Surrogate Endpoints for Rare Disease Drug Development The U.S. Food and Drug Administration is convening a one-day virtual public workshop to be held on May 18, 2026, focused on the development of surrogate endpoints for drugs and biological products intended to treat rare diseases. The agenda and new meeting materials are now publicly available. The workshop will discuss mechanistic and translational evidence considerations for supporting a novel surrogate endpoint in rare disease marketing applications, including a case study highlighting the evidentiary package to support the use of a novel surrogate endpoint. FDA, clinicians, researchers and other parties will also discuss various relevant and or emerging translational science topics to support the development of novel surrogate endpoints such as new approach methodologies, digital health technology, and harnessing varied sources of patient-level real world data. For more information about the program and meeting registration, please visit this FDA webpage. Visit CDER’s ARC website for an overview and information about the ARC Program. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/accelerating-rare-disease-cures-arc-program?utm_medium=email&utm_source=govdelivery

Development of Non-Opioid Analgesics for Acute Pain Draft Guidance for Industry May 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-acute-pain

Viewpoints: Kennedy's Misguided Push Against Antidepressants; Why Do We Keep Getting Virus Spread Wrong?

https://kffhealthnews.org/morning-breakout/viewpoints-kennedys-misguided-push-against-antidepressants-why-do-we-keep-getting-virus-spread-wrong/

A Drug's Rocky Road To Discovery May Signal Pancreatic Cancer Breakthrough

A Drug's Rocky Road To Discovery May Signal Pancreatic Cancer Breakthrough The New York Times reports on daraxonrasib, the first drug to substantially extend the lives of patients with pancreatic cancer. The cellular proteins it targets fuel the three leading causes of cancer deaths: pancreatic tumors, lung, and colon cancers. The drug is fast-tracked for review by the Food and Drug Administration and could win approval later this year. https://kffhealthnews.org/morning-breakout/cancer-2/

Federal Criminal Probe Over New York Hospital's Gender-Affirming Care Escalates

Federal Criminal Probe Over New York Hospital's Gender-Affirming Care Escalates According to The 19th, the federal government wants access to the medical records of children who have received gender-affirming care over the past six years. Also: Some states are trying to roll back disability rights; 25,000 UC Health workers are set to strike; and more. https://kffhealthnews.org/morning-breakout/states-117/

Study: Millions Of Children Can Access Loaded, Unsecured Guns At Home

Study: Millions Of Children Can Access Loaded, Unsecured Guns At Home A recent JAMA study reveals that nearly 7 million U.S. children live in homes with at least one loaded, unlocked gun. Also in the news: suicide, the yo-yo diet effect, testosterone, and more. https://kffhealthnews.org/morning-breakout/public-health-22/

Healthcare Providers Demand Stricter Rules For Medical Record Sharing

Healthcare Providers Demand Stricter Rules For Medical Record Sharing Hundreds of thousands of patients' records from health systems across the country have been compromised, The Washington Post reports. This underscores the necessity for health IT officials and executives to close security gaps in the electronic network used to transfer medical records between hospitals, physicians’ offices, and laboratories. https://kffhealthnews.org/morning-breakout/industry-news-3/