Posts

FDA Issues Complete Response Letter to Aquestive's Anaphylm Over Packaging and Human Factors Issues

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FDA Opens Submissions for PreCheck Pilot Program to Accelerate US Pharmaceutical Manufacturing Facilities

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FDA Action Alert: Upcoming Decisions on Sanofi/Regeneron, Merck, REGENXBIO and More in February 2026

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Amgen Ends Autoimmune Alliance with Kyowa Kirin for Rocatinlimab Amid Safety and Efficacy Concerns

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Eli Lilly Commits $3.5 Billion to Build Injectable Obesity Drug Plant in Pennsylvania

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Ultragenyx Resubmits BLA for UX111 Gene Therapy Targeting Sanfilippo Syndrome Type A to FDA

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Recent Developments in Jiangsu Hengrui Pharmaceuticals: Global Deals and Clinical Leadership

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KOL Bulletin: Next-Generation TYK2 Inhibitors Outperform Sotyktu in Psoriasis Trials but Fall Short of Biologics

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KOL Bulletin: Brilaroxazine's Potential Differentiation on EPS Over Risperidone in Schizophrenia

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KOL Bulletin: ONS-5010's Bigger Opportunity May Lie Outside the US After FDA's Third CRL, KOL Says

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