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orphan designation

The US Food and Drug Administration (FDA) has granted orphan drug designation to Asceneuron’s treatment of progressive supranuclear palsy (PSP) — which is a rapidly progressing rare neurodegenerative disorder. more

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Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

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Taiwanese biopharma company, OBI Pharma, has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for its treatment of hepatocellular carcinoma (HCC), OBI-3424. more

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The US Food and Drug Administration (FDA) has granted orphan drug designation to Crossject's treatment for status epilepticus (epileptic seizure lasting longer than five minutes), ZENEO Midazolam. more

Technology

The US Food and Drug Administration (FDA) has approved Addmedica’s drug Siklos (hydroxyurea tablets) for the treatment of paediatric patients, two years of age and older, suffering from sickle cell anaemia. more

Technology

Biotechnology company, GamaMabs Pharma, has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead compound GM102 to treat advanced ovarian cancers. more

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The European Commission (EC) has granted orphan designation to Apogenix’s lead product candidate, asunercept (APG101), for the treatment of myelodysplastic syndromes (MDS). more

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Motif Bio’s investigational drug candidate, iclaprim, has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis. more

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Biotech company, VAXIMM, has received orphan designation from the European Commission (EC) and the US Food and Drug Administration (FDA) for its lead product candidate, VXM01, for the treatment of glioma. more

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