Date | Compound | Laboratory | Indication | Type of Information |
---|---|---|---|---|
2015-03-31 | BG Medicine (USA - MA) | identification of patients at elevated risk for near-term adverse cardiovascular events |
Submission of an extension indication | |
2016-04-21 | fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) | Gilead Sciences (USA - CA) | HIV-1 infection |
Granting of a Market Authorisation in the EU |
2015-05-04 | clindamycin 1%-benzoyl peroxide 3% | GSK (UK) | acne vulgaris |
Granting of a Market Authorisation in Japan |
2015-04-29 | (S)-7-(1-(9H-purin-6-ylamino)ethyl)-6-(3-fluorophenyl)-3-methyl-5H-thiazolo[3,2-a]pyrimidin-5-one | Incyte (USA - DE) | Hodgkin lymphoma |
Granting of the orphan status in the US |
2015-04-16 | 177-LU-DOTA-GlyGlyNle-CycMSHhex | SolaranRx (USA - NM) | stage IIB through IV malignant melanoma |
Granting of the orphan status in the US |
2015-03-25 | Anthrax Immune Globulin Intravenous | Emergent BioSolutions (USA - MD) | inhalational anthrax |
Granting of a Market Authorisation in the US |
2015-04-01 | Baxter (USA - IL) | renal diseases |
Granting of a Market Authorisation in the EU | |
2015-06-04 | pantothenate phosphate | Retrophin (USA - CA) | pantothenate kinase-associated neurodegeneration (PKAN) |
Granting of the orphan status in the US |
2016-10-13 | synthetic sodium deoxycholate | Kythera Biopharmaceuticals (USA - CA), now Allergan (Ireland) | submental fullness (double chin) |
Granting of a Market Authorisation in the EU |
2016-02-19 | ticagrelor | AstraZeneca (UK) | secondary prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event | Granting of a Market Authorisation in the EU |
2015-04-28 | Genzyme (USA - MA), a Sanofi company (France) | Fabry disease |
Granting of a Fast Track status | |
2015-05-07 | cobiprostone | Sucampo Pharmaceuticals (USA - MD) | prevention of oral mucositis |
Granting of a Fast Track status |
2014-09-02 | particle-engineered version of fluticasone propionate | Prosonix (UK) | asthma |
Acceptation for review of a NDA |
2015-04-23 | Lutetium (177Lu) | I.D.B. Radiopharmacy (The Netherlands) | radiolabelling of carrier molecules |
Positive opinion for the granting of a Market Authorisation in the EU |
2015-09-10 | adalimumab | Abbvie (USA - IL) | moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) |
Granting of a Market Authorisation in the US |
2017-07-06 | E-selectin antagonist | GlycoMimetics (USA - MD) | acute myeloid leukemia | Granting of a patent |
2017-08-24 | amantadine hydrochloride | Adamas Pharmaceuticals (USA - CA) | dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Granting of a Market Authorisation in the US |
2015-04-09 | 2-pyrazinecarbonitrile, 5-[[5-2-(3-aminopropoxy)-6-methoxyphenyl]-1H-pyrazol-3-yl]amino] monomesylate monohydrate | Eli Lilly (USA -IN) | anal cancer |
Granting of the orphan status in the US |
2015-04-15 | 2-[4-[[(2-R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate | Cymabay Therapeutics (USA - CA) | Frederickson Type I or V hyperlipoproteinemia |
Granting of the orphan status in the US |
2015-03-18 | 2-[4-[[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate | Cymabay Therapeutics (USA - CA) | homozygous familial hypercholesterolemia (HoFH) |
Granting of the orphan status in the US |
© 2024 Biopharmanalyses - Powered by Samacom+