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Orphan Drug Designation

Showing 5 posts of 5 posts found.

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FDA grants orphan drug designation to antibody-mediated rejection treatment

June 26, 2025
Research and Development FDA, Immunology, Orphan Drug Designation, Sanofi, antibody-mediated rejection, clinical trials, immunology, inflammation, organ transplantation

Sanofi has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to riliprubart for …

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brain_mri_131749_t1

Immunotherapy created at Roswell Park Comprehensive Cancer Center given expanded ODD by FDA

June 27, 2024
Research and Development MimiVax, Oncology, Orphan Drug Designation, Roswell Park Comprehensive Cancer Center, immunotherapies, oncology

The US Food and Drug Administration (FDA) has granted an expanded Orphan Drug Designation (ODD) for brain cancer immunotherapy SurVaxM, …

News

Endogena’s retinitis pigmentosa treatment granted Orphan Drug Designation by FDA

May 12, 2021
Research and Development DFA, Endogena, Orphan Drug Designation

Endogena Therapeutics Inc has been granted Orphan Drug Designation for its EA-2353 ophthalmic suspension targeting retinitis pigmentosa by the FDA. …

News

FDA orphan drug designation doubles PhaseRx shares

November 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Orphan Drug Designation, PhaseRx

PhaseRx is celebrating as its lead drug candidate PRX-OTC has been orphan drug designation by the US FDA for the …

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azhqlondonweb

AstraZeneca says its trial drug for thyroid cancer granted US FDA orphan drug designation

May 12, 2016
Research and Development, Sales and Marketing AstraZeneca, Orphan Drug Designation, US FDA, drug trial, regulation

AstraZeneca (LSE: AZN) on Thursday said the US Food and Drug Administration (FDA) has granted Orphan Drug Designation its trial …

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