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Aquestive Therapeutics Receives U.S. FDA Orphan Drug Designation for Riluzole Oral Soluble Film to T biospace
February 01, 2018
FDA announced today that the U.S. Food and Drug Administration (FDA) has granted orphan riluzole oral soluble film (riluzole OSF) for the treatment of amyotrophic lateral sclerosis (ALS) Drug name
FDA Grants Orphan Drug Designation to Dauntless Pharma's DP1038 for the Treatment of Acromegaly biospace
January 31, 2018
Dauntless Pharmaceuticals announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DP1038
Avadel Pharmaceuticals Receives Orphan Drug Designation From FDA for FT 218 for the Treatment of Nar biospace
January 11, 2018
Avadel Pharma “Avadel” or “the Company,” today announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy.
FDA Grants Orphan Drug Designation to Zytoprotec's Novel Dialysis Fluid b3cnewswire
December 15, 2017
Zytoprotec, a biopharmaceutical company developing innovative dialysis fluids, announced today that the United States FDA) has granted orphan drug designation to PD-protec®, the Company's peritoneal dialysis fluid for the treatment of patients with end-st
EMA Grants Orphan Drug Designation to Debio 1347 americanpharmaceuticacreview
November 15, 2017
Debiopharm International announced the European Medicines Agency (EMA) granted Orphan Drug Designation to Debio 1347 for treatment of Biliary Tract Cancer affecting around 77,000 people in the European Union (EU).
Jupiter Receives Orphan Drug Designation for Trans-Resveratrol Product JOTROL americanpharmaceuticalreview
August 24, 2017
Jupiter Orphan Therapeutics (JOT) has received notification from the US Food and Drug Administration (FDA) that its Orphan Drug Designation request for trans-Resveratrol has been granted.
FDA grants orphan drug status to H3 Biomedicine’s cancer treatment H3B-8800 pharmaceutical-technology
August 17, 2017
H3 Biomedicine, a member of Eisai’s global Oncology Business Group, has received orphan drug designation from the US Food and Drug Administration (FDA) for its H3B-8800, a clinical compound used to treat patients with acute myelogenous leukaemia (AML) and
Ocugen Receives FDA Ocugen Receives FDA Orphan Drug Designation for OCU300 for Treatment of oGVHD De americanpharmaceuticalreview
August 10, 2017
Ocugen announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease (oGVHD).
Ignyta's cancer drug entrectinib receives FDA orphan drug status pharmaceutical-technology
July 12, 2017
Biotechnology firm Ignyta has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational, orally available, CNS-active tyrosine kinase inhibitor, entrectinib, to treat NTRK fusion-positive solid tumours.
FDA Grants Orphan Drug Designation for Investigational WT1 Cancer Peptide Vaccine DSP-7888 americanpharmaceuticalreview
July 11, 2017
Boston Biomedical announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndrome (MDS).

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