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Petition Urges FDA to Overhaul Biosimilar Approval Rules
BioNTech, OncoC4 See Good Survival Data for Lung Cancer Drug
FDA Delays Decision on Agios Mitapivat sNDA for Thalassemia
Dyne Reports Strong Dystrophin Gains in Duchenne Study
Device Compliance Official Flags Quality Gaps, Rising Enforcement
Breyanzi OKd for Hard-to-Treat Marginal Zone Lymphoma
Praxis Epilepsy Drug Study Stopped for Positive Efficacy
FDA 483 Cites Apotex Over Sterility, Data Integrity Failures

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