The FDA commissioner publicly defended the agency’s drug approval decisions, responding to criticism from pharmaceutical companies and some lawmakers, emphasizing that approval standards will not be lowered under political pressure.
The FDA has granted expanded access to Revolution Medicines’ targeted pancreatic cancer drug daraxonrasib, opening a pathway for more patients to receive a therapy that has shown promising results in clinical trials.
The FDA approves an expanded access program for daraxonrasib, an innovative pancreatic cancer drug that showed promising results in clinical trials, offering new hope for patients with one of the most challenging cancers.
The US FDA has announced plans to introduce AI and real-time data technology to accelerate drug clinical trial approvals, marking a fundamental shift in drug development regulatory processes.