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2023
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Labeling Changes for Aduhelm Detail Risks of ARIA Brain Bleeds
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Soligenix Gets Refusal to File Letter for HyBryte in Cutaneous T-Cell Lymphoma
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FDA Places Partial Clinical Hold on Blueprint Medicines Trial
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EMA to Review Pseudoephedrine Drugs
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Frequency Therapeutics Announces Topline Results for its Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss
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GSK’s Jemperli Gets Regular Approval for Endometrial Cancer
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FDA Accepts Biologics License Application for Proposed Biosimilar Denosumab
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FDA Extends Ibuprofen Suspension Guidance
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FDA Approves Regeneron’s Eylea for Infants With ROP
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FDA Expands Approval for Takeda’s Takhzyro