An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...

May 7 (Reuters) - Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug Administration classified the action as its most serious recall, the ...

May 7 (Reuters) - Boston Scientific (BSX.N), opens new tab has issued an urgent recall to correct several heart devices after the U.S. Food and Drug Administration classified the action as its ‌most ...

The Food and Drug Administration said Boston Scientific will upgrade certain pacemakers to a new software as part of a recall. Boston Scientific issued a letter to affected customers recommending all ...

Despite Health Secretary Robert F. Kennedy’s pledge to provide “radical transparency,” the agencies under his control continue to suppress scientific research that conflicts with his anti-vaccine ...

Sarah covers how industries like food and tobacco affect Americans’ bodies and minds. Her interests include ultra-processed foods; smoke-free tobacco; and wellness trends like perimenopause products ...

The Food and Drug Administration’s flagship internal AI tool, Elsa, is being integrated with the data platform so that staff can accomplish work more easily. FDA Data Governance IT Modernization The ...

For patients whose skin cancer doesn’t respond to traditional treatments, a new drug called RP1 has been a lifeline—at least for those who can get into a clinical trial. The drug has shown so much ...

Kyverna Therapeutics has unveiled the full results from its registrational trial of miv-cel in stiff person syndrome (SPS), providing a comprehensive look at what could become the first-ever CAR-T ...

The White House is pushing to allow more vape flavors on the market for the first time in years, but Food and Drug Administration Commissioner Marty Makary opposes the move and is blocking the plan, ...