October 5, 2022
FDA Unveils Rare Disease Endpoint Advancement Pilot Program
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June 24, 2022
FDA Releases Action Plan for Rare Neurodegenerative Diseases, Including ALS
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May 11, 2022
FDA’s CDER Launches Accelerating Rare Disease Cures Program
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April 12, 2022
Marksist Thought and Capital Ideas
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March 15, 2022
FDA Releases Draft Guidance for Gene Editing Products
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December 8, 2021
FDA Issues Guidances on N-of-1 ASO Therapies
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November 30, 2021
FDA Issues Draft Guidance on Use of Registries to Support Regulatory Decision-Making
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October 1, 2021
Court Supports Catalyst Pharma’s Appeal for Orphan Drug Exclusivity for Firdapse for LEMS
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October 1, 2021
FDA Issues Draft Guidance on Real-World Evidence
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September 21, 2021
FDA Should Look to Past Precedents When Applying Flexibility to Approvals to Maintain Public Trust, Study Says
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May 25, 2021
FDA Approves First Therapy for Rare Form of NSCLC with Companion Diagnostic
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