News

FDA Approves Once-Monthly Andembry for Hereditary Angioedema
By Lori Solomon HealthDay ReporterFRIDAY, June 20, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
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Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...
US judge upholds FDA's removal of Ozempic, Wegovy from drug shortage list
By Diana Novak Jones (Reuters) -A federal judge has rejected a bid by compounding pharmacies to allow them to continue making ...
Ginger Beer Recall Update as FDA Issues Highest Risk Warning
Rachel's Ginger Beer issued a voluntary recall for its "Cucumber x Tarragon Ginger Beer" in November last year due to ...
FDA approves the world’s only twice-a-year shot to prevent HIV
The Food and Drug Administration has approved the world’s only twice-a-year shot to prevent HIV. In two groundbreaking ...
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As AI device market grows, FDA’s accounting goes silent
As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.
FDA announces sweeping changes to speed up the drug review process
An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...
Gene Therapy Stocks Fall as FDA Pushes Out Another Top Regulator
The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...