The Food and Drug Administration on Thursday shared a strategic plan to completely eliminate the agency’s backlog of orphan drug designation requests. The plan comes a week after FDA Commissioner ...
Less than two weeks after posting a scathing Form 483 filing, the FDA slammed Chinese API maker Sichuan Deebio Pharmaceuticals with a warning letter (PDF) citing “significant deviations” in its ...
The U.S. Food and Drug Administration (FDA) is warning consumers, patients and health care providers about the potential risk ...
On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
Rybelsus is now FDA-approved for managing cardiovascular health. Doctors say oral GLP-1s may reduce heart attack and stroke ...
Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps ...
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