FDA authorizes compassionate use of urcosimod for neuropathic corneal pain, a condition that causes severe pain and ...

Using real-world data from over 300,000 cases, scientists uncovered a significant link between semaglutide and reported vision problems—raising new concerns about the safety profile of this ...

WASHINGTON — Shortly before he was forced to resign, the nation’s top vaccine regulator says he refused to grant Health Secretary Robert F. Kennedy Jr.’s team unrestricted access to a tightly held ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

WASHINGTON (AP) — Shortly before he was forced to resign, the nation’s top vaccine regulator says he refused to grant Health Secretary Robert F. Kennedy Jr.’s team unrestricted access to a tightly ...

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 ...

Marbán indicated, "We expect to report top line data within the next few weeks." The company plans to submit HOPE-3 results as a formal complete response to the FDA's complete response letter, aiming ...

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...

The CMS created ACCESS to address barriers to care stemming from Medicare’s fee-for-service payment model. Rather than pay for specific services, Medicare will make recurring payments to healthcare ...