Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-10-28 | betamethasone | Grace Therapeutics (USA - NJ) | ataxia telangiectasia |
Granting of a patent |
2015-09-29 | 4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl | REcursion Pharmaceuticals (USA - UT) | cerebral cavernous malformation |
Granting of the orphan status in the US |
2015-09-18 | (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide (2R,3R)-2,3-dihydroxybutanedioate | Abbvie (USA - IL) | pediatric (0 through 16 years of age) juvenile idiopathic arthritis (JIA) categories excluding systemic JIA. |
Granting of the orphan status in the US |
2015-10-22 | (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)-benzamide | Acerta Pharma (USA - CA, The Netherlands), now AstraZeneca (UK) | Waldenstrom macroglobulinemia | Granting of the orphan status in the US |
2015-10-22 | bucillamine | Revive Therapeutics (Canada) | cystinuria |
Granting of the orphan status in the US |
2017-10-31 | acalabrutinib - (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazine-1-yl)-N-(pyridine-2-yl)-benzamide | Acerta Pharma (USA - CA, The Netherlands), now AstraZeneca (UK) | mantle cell lymphoma | Granting of a Market Authorisation in the US |
2016-02-25 | nivolumab | BMS (USA - NY) | advanced or metastatic renal cell carcinoma |
Positive opinion for the granting of a Market Authorisation in the EU |
2016-05-11 | nivolumab and ipilimumab | BMS (USA - NY) | previously untreated advanced melanoma |
Granting of a Market Authorisation in the EU |
2015-10-06 | S)-8-{2-Amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester | Karos Pharmaceuticals (USA - CT) | pulmonary arterial hypertension (PAH) |
Granting of the orphan status in the US |
2015-09-15 | nivolumab | BMS (USA - NY) | small cell lung cancer |
Granting of the orphan status in the US |
2015-12-14 | 2-(2-chlorobenzylidene)hydrazinecarboximidamide acetate | Inflectis Bioscience (France) | Charcot-Marie Tooth disease | Granting of the orphan status in the EU |
2015-09-29 | 2-[(4S)-6-(4-chlorophenyl)-1,7,8-trimethylthiophenol[3,2-f]1,2,4-triazolo[4,3-a]1,4-diazepin-4-yl]-N-[3-(4-methylpiperazinyl)propyl]acetamide | Tensha Therapeutics (USA - MA) | treatment of nuclear protein in testis (NUT) midline carcinoma. |
Granting of the orphan status in the US |
2015-12-14 | 2-amino-2-[2-[2-chloro-4-[[3-(phenylmethoxy) phenyl] thio]phenyl]ethyl]1,3-propanediol hydrochloride | Novartis (Switzerland) | graft-versus-host disease
|
Granting of the orphan status in the EU |
2015-10-28 | ABCA4 DNA nanoparticles | Copernicus Therapeutics (USA - OH) | Stargardt Macular Degeneration |
Granting of the orphan status in the US |
2015-10-28 | baclofen | Mallinckrodt (UK) | complex regional pain syndrome |
Granting of the orphan status in the US |
2015-09-29 | guadecitabine | Astex Pharmaceuticals (USA - CA) | acute myeloid leukemia |
Granting of the orphan status in the US |
2015-11-02 | skin allograft | Osiris Therapeutics (USA - MD) | chronic wounds |
Product launch |
2015-11-02 | pembrolizumab (MK-3475) | Merck&Co (USA - NJ) | advanced colorectal cancer | Granting of the Breakthrough Therapy status |
2015-10-27 | paricalcitol | Abbvie (USA –IL) | pediatric hyperparathyroidism |
Granting of the orphan status in the US |
2015-10-14 | ondansetron inhalation powder | Luxena Pharmaceuticals (USA – CA) | prevention of chemotherapy-induced nausea and vomiting due to highly emetogenic chemotherapy in pediatric patients (0 through 16 years of age) |
Granting of the orphan status in the US |
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