Category: Drug Approvals
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FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients
The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently…
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FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain…
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FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without…
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FDA Expands AI Capabilities and Completes Data Platform Consolidation
FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the…