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Moleculin Biotech Secures Hong Kong Patent for Liposomal Annamycin Ahead of Phase 3 Data
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FDA Issues Final Guidance on Postapproval Pregnancy Safety Studies for Drugs and Biologics

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Moleculin Biotech Secures Hong Kong Patent for Liposomal Annamycin Ahead of Phase 3 Data

Moleculin Biotech adds Hong Kong to its Annamycin IP portfolio ahead of imminent Phase 3 data, extending formulation exclusivity through 2040.

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FDA Issues Final Guidance on Postapproval Pregnancy Safety Studies for Drugs and Biologics

FDA's final guidance on postapproval pregnancy safety studies sets a methodological framework covering registries, real-world data, and case-based descriptive studies.

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FDA Finalizes Pulmonary TB Drug Development Guidance for Antibacterial Sponsors in 2026

FDA finalizes pulmonary TB drug development guidance under docket FDA-2013-D-1319, setting clinical trial expectations for antibacterial sponsors.

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FDA Finalizes CDI Drug Development Guidance Covering Treatment, Recurrence Reduction, and Prevention Pathways

FDA finalizes CDI drug development guidance under docket FDA-2022-D-1261, covering treatment, recurrence reduction, and prevention indication pathways.

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