Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2014-04-11 | recombinant human surfactant protein D | Dr Ulrich Granzer (Germany) | bronchopulmonary dysplasia |
Granting of the orphan status in the EU |
2014-02-23 | adeno-associated viral vector serotype 8 containing the human GUCY2D gene | Fondazione Telethon (Italy) | Leber’s congenital amaurosis | Granting of the orphan status in the EU |
2018-09-28 | amikacin sulfate (liposomal amikacin for inhalation) | Insmed Limited (USA - NJ) | nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC) | Granting of a Market Authorisation in the US |
2014-02-23 | autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene | Prof. F.J.T. Staal (The Netherlands) | recombination-activating gene 1 deficient severe combined immunodeficiency |
Granting of the orphan status in the EU |
2014-02-23 | doxorubicin (6-maleimidocaproyl) hydrazone | Eudax (Italy) | soft tissue sarcoma |
Granting of the orphan status in the EU |
2014-02-23 | fixed-dose combination of (R-S) baclofen, naltrexone hydrochloride and D-sorbitol | Pharnext (France) | Charcot-Marie-Tooth disease type 1A | Granting of the orphan status in the US |
2014-02-24 | propranolol | Pierre Fabre Dermatologie (France) | proliferating infantile haemangioma requiring systemic therapy | Granting of a Market Authorisation in the US |
2014-08-08 | canagliflozin and metformin | Janssen-Cilag International - a J&J company (USA - NJ) | type 2 diabetes mellitus |
Granting of a Market Authorisation in the US |
2014-02-24 | PLacental eXpanded (PLX-PAD) cells | Pluristem Therapeutics (Israel) | severe preeclampsia | |
2014-02-24 | 9-valent human papillomavirus vaccine | Merck&Co (USA) | prevention of human papillomavirus (HPV) infection |
Acceptation for review of a NDA |
2014-07-07 | daclatasvir and asunaprevir | BMS (USA) | genotype 1b chronic hepatitis C (HCV) infection |
Granting of a Market Authorisation in Japan |
2014-02-25 | gevokizumab | Xoma (USA - CA) Servier (France) | pyoderma gangrenosum |
Granting of the orphan status in the US |
2015-03-30 | oritavancin | Melinta Therapeutics (USA - CT) |
|
Granting of a Market Authorisation in the EU |
2014-03-03 | cadazolid | Actelion (Switzerland) | Clostridium difficile-associated diarrhea (CDAD) |
Granting of a Fast Track status |
2015-03-23 | tedizolid phosphate | Cubist Pharmaceuticals (USA - MA) | adult acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococccus faecalis. |
Granting of a Market Authorisation in the EU |
2014-10-15 | cannabidiol (2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) | GW Pharmaceuticals (UK) | Dravet syndrome |
Granting of the orphan status in the EU |
2017-03-20 | cannabidiol (2-[(1R,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) | GW Pharmaceuticals (UK) | Lennox-Gastaut syndrome | Granting of the orphan status in the EU |
2014-03-08 | cholic acid | CTRS (France) | adults and children from one month of age who have a genetic abnormality that makes them unable to produce bile. Orphacol is used in patients who do not have enough of two specific liver enzymes (3β-hydroxy-Δ5-C27-steroid dehydrogenase/isomerase or Δ4-3-oxosteroid 5β- reductase) |
Granting of a Market Authorisation in the EU |
2014-03-11 | cholest-4-en-3-one, oxime | Trophos (France) | spinal muscular atrophy | |
2018-10-05 | autologous CD34+ haematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human beta A-T87Q-globin gene | bluebird bio (USA - MA) | sickle cell disease - beta-thalassemia major | Acceptation for review of a NDA |
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