FDA authorizes compassionate use of urcosimod for neuropathic corneal pain, a condition that causes severe pain and sensitivity of the eyes, face, or head.

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 ...

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 ...

On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine. The agency said it would approve new versions of the vaccine only for adults 65 ...

Food and Drug Administration officials plan to present data they claim links the Covid vaccine to 25 deaths in children at what’s expected to be a closely watched vaccine advisory committee next week, ...

The FDA has granted fast track designation to LBL-034 for patients with relapsed or refractory multiple myeloma. The U.S.

The National Institutes of Health (“NIH”) has become the latest federal agency to impose obligations that go beyond those required by the watershed U.S. Department of Justice (“DOJ”) data security ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...

A look at how efficiency, access, platformization, AI, non-traditional players, and regulatory recovery are expected to reshape clinical operations in 2026. As sponsors, CROs, regulators, and ...