Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

Echosens, the leader in non-invasive liver diagnostics, is announcing today that the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), Office of New Drugs has ...

While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular ...

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

The US Food and Drug Administration (FDA) has created a new pathway to streamline rare disease drugs through regulatory ...

Following the departure of Vinay Prasad, M.D., former head of the Center for Biologics Evaluation and Research (CBER), the FDA has already tapped someone else to temporarily fill his shoes. Freshly ...

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...

FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.

John Wilkerson is a Washington correspondent for STAT who writes about the politics of health care. He is also the author of the twice-weekly D.C. Diagnosis newsletter. You’re reading the web edition ...