WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a new centralized system that will allow scientists, ...

The FDA launched AEMS, a unified platform that replaces fragmented legacy databases to enable real-time adverse event reporting.

System will replace safety databases monitoring drugs, devices, food, and more ...

After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance ...

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device ...

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the FDA Technology-Enabled Meaningful Patient Outcomes ...

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 ...

FDA NDA acceptance for lorundrostat, Dec 2026 PDUFA, cash runway & launch plans for resistant hypertension—Read now.