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Brief
On March 11, 2025, the U.S. Food and Drug Administration (FDA) took multiple regulatory actions. The FDA issued a General Correspondence Letter to Mid-Link Technology Testing Co., Ltd., citing concerns over falsified and unreliable testing data, leading to the rejection of all study data from the facility until issues are resolved. The agency also sent six warning letters to companies selling unapproved fat-dissolving injectables, reinforcing consumer safety concerns. Additionally, the FDA approved Omlyclo (omalizumab-igec), the first interchangeable biosimilar to Xolair, for treating allergic, inflammatory, and autoimmune conditions.
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