Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-04-08 | modified human papillomavirus capsid protein conjugated to a near infrared dye | Aura Biosciences (USA - MA) | uveal melanoma |
Granting of the orphan status in the US |
2015-03-24 | mouse-human chimeric antibody of the IgG1 isotype, directed against human CD37 | Boehringer Ingelheim (Germany) | chronic lymphocytic leukemia |
Granting of the orphan status in the US |
2016-06-16 | obinutuzumab | Genentech, a member of Roche Group (USA - CA - Switzerland) Roche (Switzerland) | follicular lymphoma | Granting of a Market Authorisation in the EU |
2015-04-22 | recombinant human histidyl tRNA synthetase (505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase) | Atyr Pharma (USA - CA) Voisin Consulting (France) | facioscapulohumeral muscular dystrophy |
Granting of the orphan status in the US |
2015-05-18 | revusiran | Alnylam Therapeutics (USA - MA) | transthyretin amyloidosis | Granting of the orphan status in the US |
2015-03-16 | pegylated human recombinant arginase I | AERase (USA - TX) | arginase I deficiency (hyperargininemia) |
Granting of the orphan status in the US |
2015-05-04 | pelareorep (human reovirus type 3 Dearing strain) | Oncolytics Biotech (Canada) | gastric cancer |
Granting of the orphan status in the US |
2015-03-18 | methotrexate oral liquid formulation | Chesapeake Therapeutics (USA - MD) | acute lymphoblastic leukemia in pediatric patients aged 0 through 16 years. |
Granting of the orphan status in the US |
2015-05-21 | poly-CD-PEG-camptothecin | Cerulean Pharma (USA - MA) | ovarian cancer |
Granting of the orphan status in the US |
2015-03-17 | polyethylene glycol modified recombinant C-terminal truncate of human cystathionine beta-synthase | Orphan Technologies (Virgin Islands) | homocystinuria |
Granting of the orphan status in the US |
2015-03-16 | hydroxyurea | Ebelle D\'Ebelle Pharmaceuticals (USA - NJ) | symptomatic sickle cell disease in pediatric patients, less than 17 years of age |
Granting of the orphan status in the US |
2015-04-27 | liposomal P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide | Bio-Path Holdings (USA - TX) | acute myeloid leukemia |
Granting of the orphan status in the US |
2015-04-08 | treosulfan | Medac (Germany) | conditioning treatment prior to hematopoietic stem cell transplantation (HSCT) in malignant and non-malignant diseases in adults and pediatric patients |
Granting of the orphan status in the US |
2015-04-15 | triheptanoin | Ultragenyx Pharmaceutical (USA - CA) | fatty acid oxidation disorders | Granting of the orphan status in the US |
2015-05-18 | xenon gas | Neuroprotexeon (UK) | improvement of neurological outcome in hospitalized cardiac arrest patients |
Granting of the orphan status in the US |
2015-04-15 | zoledronate D,L-lysine monohydrate (ZLM) | Thar Pharmaceuticals (USA - PA) | complex regional pain syndrome (CRPS) |
Granting of the orphan status in the US |
2015-05-26 | house dust mite immunotherapy tablet | Shionogi (Japan) Stallergenes (France) | house dust mite induced allergic rhinitis |
Granting of a Market Authorisation in Japan |
2015-03-23 | sonidegib - LDE225 | Novartis (Switzerland) | medulloblastoma |
Granting of the orphan status in the US |
2015-03-25 | monitoring test of ustekinumab | Theradiag (France) | psoriasis psoriatic arthritis |
Granting of a Market Authorisation in the EU |
2015-09-15 | 20 percent concentration subcutaneous immune globulin (IGSC) treatmentI | Baxalta (USA - IL) | primary immunodeficiencies |
Submission of a Market Application in the US |
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