I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research.

While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and ...

TAMPA, Fla., July 11, 2025 (GLOBE NEWSWIRE) -- Full Alliance Group Inc. (OTC: FAGI) and its fifty one percent owned subsidiary, Aquaox Pure Solutions, LLC, announce two pivotal regulatory achievements ...

In record-breaking operation, federal officials seized 4.7 million unauthorized e-cigarette products with an estimated retail ...

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

– RMAT designation granted for rese-cel in myositis, which is a disabling, multi-system autoimmune disease affecting approximately 80,000 U.S. patients with no approved treatments other than monthly ...