Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-01-26 | leukotriene A4 hydrolase inhibitor | Celtaxsys (USA - GA) | cystic fibrosis |
Granting of the orphan status in the US |
2015-02-10 | levomefolate calcium | Cox Biosciences (USA - NY) | megaloblastic anemia caused by folate deficiency |
Granting of the orphan status in the US |
2015-01-21 | liposomal encapsulated paclitaxel | Insys Therapeutics (USA - AZ) | ovarian cancer |
Granting of the orphan status in the US |
2015-01-27 | isinopril oral solution | codaDose (USA - GA) | Granting of the orphan status in the US | |
2017-09-14 | copanlisib | Bayer Healthcare (Germany) | follicular lymphoma | Granting of a Market Authorisation in the US |
2015-01-26 | human leukocyte antigen-A2 restricted peptides | Stemline Therapeutics (USA - NY) | glioma |
Granting of the orphan status in the US |
2015-01-27 | filgrastim | Neurovision Pharma (Germany) | amyotrophic lateral sclerosis (ALS) |
Granting of the orphan status in the US |
2015-01-21 | antroquinonol | Golden Biotechnology (Taiwan) | pancreatic cancer |
Granting of the orphan status in the US |
2015-02-03 | antinuclear antibody conjugated liposomal doxorubicin | NanoSmart Pharmaceuticals (USA - CA) | Ewing's sarcoma. |
Granting of the orphan status in the US |
2015-01-26 | Theranost 68Ga RGD | Advanced Imaging Projects (USA - FL) | diagnostic for the clinical management of patients with tuberculosis |
Granting of the orphan status in the US |
2015-02-03 | N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide | Ignyta (USA - CA) |
|
Granting of the orphan status in the US |
2015-02-13 | oxycodone hydrochloride and naltrexone hydrochloride | Pfizer (USA - NY) | management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate |
Acceptation for review of a NDA |
2014-11-17 | (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide | ChemoCentryx (USA - CA) | atypical Hemolytic Uremic Syndrome (aHUS) |
Granting of the orphan status in the US |
2016-05-26 | carfilzomib | Amgen (USA - CA) Onyx Pharmaceuticals (USA - CA) | patients with relapsed multiple myeloma who have received at least one prior therapy patients with multiple myeloma who have received one to three prior lines of therapy |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-02-02 | olopatadine hydrochloride ophthalmic solution | Alcon (USA - TX), a Novartis company (Switzerland) | ocular itching associated with allergic conjunctivitis |
Granting of a Market Authorisation in the US |
2015-08-20 | sonidegib - LDE225 | Novartis (Switzerland) | loally advanced basal cell carcinoma | Granting of a Market Authorisation in the EU |
2016-01-25 | ramucirumab in combination with docetaxel | Eli Lilly (USA - IN) | metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy |
Granting of a Market Authorisation in the EU |
2015-02-23 | rindopepimut (L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyanin) | Celldex Therapeutics (USA - NJ) | EGFRvIII-positive glioblastoma |
Granting of the Breakthrough Therapy status |
2015-02-26 | bioMérieux (France) BioFire Diagnostics (USA - UT) | infectious diseases |
Granting of a Market Authorisation in the US | |
2017-10-02 | ceftazidime-avibactam | AstraZeneca (UK) - Forest Laboratories (USA - NJ), an Actavis' subsidiary (Ireland), now Allergan (Ireland) |
|
Acceptation for review of a sNDA |
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