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2023
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FDA Updates Safety Labeling and Prescribing Information for Opioid Pain Meds
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Selective Target Activity Profiling Library
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FDA grants breakthrough device status for Genetesis’ CardioFlux MCG
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FDA rejects Eli Lilly’s mirikizumab for ulcerative colitis, citing manufacturing concerns
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Regenxbio Gene Therapy Candidate Gets Fast Track Status for Duchenne Muscular Dystrophy
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FDA Accepts sBLA for Pembrolizumab Plus Chemotherapy in Advanced Gastric/GEJ Adenocarcinoma
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The FDA Commissioner Who Approved the Abortion Pill Is Still Fighting for It
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Biogen to develop amyloid beta-targeting antibody platform
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Sumitomo Pharma’s Ewing Sarcoma Candidate Gains Orphan Drug Status
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Potential Nitrosamine Contamination Results in Another Voluntary Pharmaceutical Recall