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FDA Issues Draft Guidance on Use of Registries to Support Regulatory Decision-Making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FDA Issues Draft Guidance on Real-World Evidence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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May 24, 2021
Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic
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May 24, 2021
CHMP Recommends Approval of Therapies to Treat the Rare Disorders PFIC and POMC
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May 4, 2021
Acella Issues Voluntary Nationwide Recall of Certain Lots of Thyroid Tablets Due to Sub Potency
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April 27, 2021
FDA Issues Guidance on Individualized ASOs for Ultra-Rare Conditions
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March 10, 2021
FDA Approves Second Sight Medical Products’ Retinal Prosthesis System
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