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orphan drugs

The US Food and Drug Administration (FDA) has granted orphan drug designation to SY-1425, which is an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist for the treatment of acute myeloid leukaemia (AML) from Syros more

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An immunotherapy developed at Roswell Park Cancer Institute has been granted orphan drug status by the US Food and Drug Administration (FDA). more

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The US Food and Drug Administration (FDA) has revealed its strategic plan to eliminate its orphan designation request backlog and to ensure there is continued timely response to new requests. more

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The FDA has not granted orphan drug designation (ODD) to CytoDyn for its PRO 140 therapy as it appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested. more

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RedHill Biopharma has announced that its treatment for cholangiocarcinoma, Yeliva (ABC294640), has been granted orphan drug designation by the FDA. more

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During its March 2017 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including three orphans. more

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A new report by research group EvaluatePharma has highlighted the strength of the orphan drugs market. more

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Orphan drugs, CMO continuous manufacturing and developing world sales offer biggest revenue opportunities, say the experts. more

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Boyds has joined CTD Holdings’ International Clinical Program team, along with Aptus Clinical and KJC Statistics, to develop orphan drug Trappsol Cyclo with Accenture. more

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