FDA to tighten vaccine approval
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The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to ...
The FDA has approved Hyrnuo for some with locally advanced or metastatic non-squamous non–small cell lung cancer with ...
FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance ...
Learn why understanding the FDA’s 510(k) database is essential for every MedTech manufacturer. Discover how it supports competitive analysis, regulatory planning, faster approvals, and smarter product ...
Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...
A new FDA approval for a first-in-class drug has vaulted Otsuka into immunoglobulin A nephropathy (IgAN), an increasingly competitive kidney disease field targeted by multiple biopharma companies.
In 2024, the FDA granted a record 63 designations to antibody drug conjugates (ADCs), nearly double the previous high of 35 ...
The lab, led by Carleara Weiss, explores the relationship between Alzheimer’s disease and biomarkers of neurodegeneration, ...
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