US FDA to monitor clinical trial data in real time in pilot program aimed at speeding approvals

By Ahmed Aboulenein WASHINGTON, April 28 (Reuters) - The U.S. Food and Drug Administration launched a pilot program on Monday aimed at allowing the agency to monitor clinical trial data in real time, ...
Targeted Oncology

Daraxonrasib Demand Grows Amid Expanded Access Rollout in Metastatic PDAC

FDA opens expanded access to daraxonrasib for metastatic pancreatic cancer, as phase 3 data boost survival and clinics race ...
Morning Overview on MSN

The government just greenlit a daraxonrasib expanded-access program for pancreatic-cancer patients with the KRAS G12C mutation — opening the new targe…

For the roughly 1 to 2 percent of pancreatic-cancer patients whose tumors carry a specific genetic glitch called KRAS G12C, ...
JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
The American Journal of Managed Care

Global Gaps in Drug Access After FDA Approval: Insights From New Study and Ethics Guidelines

Lower-income countries rarely gain timely access to FDA-approved drugs tested in their populations, highlighting major global and ethical disparities. Physical access was defined as where a tested ...
Hosted on MSN

FDA says "manipulated" data backed approval, moves to withdraw the drug

The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up the drug’s 2021 approval for a rare and potentially fatal blood vessel ...