Tag «Priority review»

ブレキサノロン , Brexanolone, Allopregnanolone

Brexanolone 318.501 g/mol, C21H34O2 CAS: 516-54-1 ブレキサノロン MFCD00003677 Pregnan-20-one, 3-hydroxy-, (3α,5α)- Pregnan-20-one, 3-hydroxy-, (3α,5α)- [ACD/Index Name] S39XZ5QV8Y TU4383000 UNII:S39XZ5QV8Y (1S,2S,7S,11S,14S,15S,5R,10R)-14-acetyl-5-hydroxy-2,15-dimethyltetracyclo[8.7.0.0<2,7>.0<11,15>]heptadecane (+)-3a-Hydroxy-5a-pregnan-20-one (+)-3α-Hydroxy-5α-pregnan-20-one (3α,5α)-3-Hydroxypregnan-20-one [ACD/IUPAC Name] 10446 3211363 [Beilstein] 3a-Hydroxy-5a-pregnan-20-one The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug …

Caplacizumab-yhdp, カプラシズマブ

FDA approves first therapy Cablivi (caplacizumab-yhdp) カプラシズマブ , for the treatment of adult patients with a rare blood clotting disorder FDA February 6, 2019 Release https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630851.htm?utm_campaign=020919_PR_FDA%20approves%20therapy%20for%20treatment%20of%20adult%20patients%20with%20rare%20blood%20clotting%20disorder&utm_medium=email&utm_source=Eloqua The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult …

USFDA approval to Lumoxiti (moxetumomab pasudotoxtdfk) a new treatment for hairy cell leukemia

USFDA approval to Lumoxiti is a new treatment for hairy cell leukemia On September 13, 2018, the U.S. Food and Drug Administration approved Lumoxiti (moxetumomab pasudotoxtdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory Hairy Cell Leukemia (HCL) who have received at least two prior systemic therapies, including treatment …

FDA approves first drug Oxervate (cenegermin) for neurotrophic keratitis, a rare eye disease

http://www.who.int/medicines/publications/druginformation/issues/77_INN_Recommended_List.pdf Active Substance General information The active substance in Oxervate, cenegermin, is a recombinant human Nerve Growth factor (rhNGF) produced in E. coli strain HMS174. The molecule is identical to human Nerve Growth factor (NGF), a naturally occurring human protein. In humans, NGF is naturally produced as pre-pro-peptide, secreted into the endoplasmic reticulum and cleaved …

Patisiran

Patisiran Sense strand: GUAACCAAGAGUAUUCCAUdTdT Anti-sense strand: AUGGAAUACUCUUGGUUACdTdT RNA, (A-U-G-G-A-A-Um-A-C-U-C-U-U-G-G-U-Um-A-C-dT-dT), complex with RNA (G-Um-A-A-Cm-Cm-A-A-G-A-G-Um-A-Um-Um-Cm-Cm-A-Um-dT-dT) (1:1), ALN-18328, 6024128 , ALN-TTR02 , GENZ-438027 , SAR-438037 , 50FKX8CB2Y (UNII code) for RNA, (A-U-G-G-A-A-Um-A-C-U-C-U-U-G-G-U-Um-A-C-dT-dT), complex with RNA(G-Um-A-A-Cm-Cm-A-A-G-A-G-Um-A-Um-Um-Cm-Cm-A-Um-dT-dT) (1:1) Nucleic Acid Sequence Sequence Length: 42, 21, 2112 a 7 c 7 g 4 t 12 umultistranded (2); modified CAS 1420706-45-1 Treatment of Amyloidosis, SEE…..https://endpts.com/gung-ho-alnylam-lands-historic-fda-ok-on-patisiran-revving-up-the-first-global-rollout-for-an-rnai-breakthrough/ Lipid-nanoparticle-encapsulated double-stranded siRNA targeting …

FDA approves first treatment Azedra (iobenguane I 131) for rare adrenal tumors

Iobenguane I 131 FDA approves first treatment for rare adrenal tumors The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed …

TAFENOQUINE, タフェノキン

Tafenoquine タフェノキン N-[2,6-dimethoxy-4-methyl-5-[3-(trifluoromethyl)phenoxy]quinolin-8-yl]pentane-1,4-diamine 1,4-Pentanediamine, N4-[2,6-dimethoxy-4-methyl-5-[3-(trifluoromethyl)phenoxy]-8-quinolinyl]- 106635-80-7 [RN] 262P8GS9L9 7835 N4-{2,6-Dimethoxy-4-methyl-5-[3-(trifluormethyl)phenoxy]-8-chinolinyl}-1,4-pentandiamin WR-238605, WR 238605, cas no 106635-80-7, Tafenoquine succinate, Etaquine, SB-252263, WR-238605 N(4)-(2,6-Dimethoxy-4-methyl-5-((3-trifluoromethyl)phenoxy)-8-quinolinyl)-1,4-pentanediamine Molecular Formula: C24H28F3N3O3 Molecular Weight: 463.49263 Medicines for Malaria Venture Walter Reed Army Institute (Originator) PATENT US 4617394 Synonyms Etaquine[5] WR 238605 [5] SB-252263 New Drug Application (NDA): 210795 Company: GLAXOSMITHKLINE FDA approved on July 20, 2018 FDA NDA 210795 Orphan This new …

Ivosidenib, ивосидениб , إيفوزيدينيب , 艾伏尼布 ,

Ivosidenib AG-120; TIBSOVO FDA approves first targeted treatment Tibsovo (ivosidenib) for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic …

Tecovirimat

Tecovirimat Molecular FormulaC19H15F3N2O3 Average mass376.329 Da 816458-31-8 [RN] 869572-92-9 [RN] UNII-F925RR824R тековиримат [Russian] تيكوفيريمات [Arabic] 替韦立马 [Chinese] Benzamide, N-[(3aR,4R,4aR,5aS,6S,6aS)-3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop[f]isoindol-2(1H)-yl]-4-(trifluoromethyl)- N-[(1R,2R,6S,7S,8S,10R)-3,5-Dioxo-4-azatetracyclo[5.3.2.02,6.08,10]dodec-11-en-4-yl]-4-(trifluoromethyl)benzamide INGREDIENT UNII CAS INCHI KEY Tecovirimat monohydrate SB96YO2BR8 1162664-19-8 QRHXYGPOQKLBJP-NPIFKJBVSA-N Tecovirimat, sold under the brand name Tpoxx among others,[6] is an antiviral medication with activity against orthopoxviruses such as smallpox and monkeypox.[4][7][8] It is the first antipoxviral drug approved in the United States.[9][10] It is an inhibitor of the orthopoxvirus VP37 …

Isavuconazonium sulfate, Изавуконазониев сулфат

Isavuconazonium sulfate Изавуконазониев сулфат CAS 946075-13-4 MOLECULAR FORMULA: C35H36F2N8O9S2 MOLECULAR WEIGHT: 814.837 g/mol BAL-8557-002, BAL 8557 [2-[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1,2,4-triazol-4-ium-4-yl]ethoxycarbonyl-methylamino]pyridin-3-yl]methyl 2-(methylamino)acetate;hydrogen sulfate UNII:31Q44514JV (2-{[(1-{1-[(2R,3R)-3-[4-(4-cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1H-1,2,4-triazol-4-ium-4-yl}ethoxy)carbonyl](methyl)amino}pyridin-3-yl)methyl N-methylglycinate hydrogen sulfate (2-{[(1-{1-[(2R,3R)-3-[4-(4-Cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1H-1,2,4-triazol-4-ium-4-yl}ethoxy)carbonyl](methyl)amino}-3-pyridinyl)methyl N-methylglycinate hydrog en sulfate FDA 2015, EU 2015, BAL8557-002, BCS CLASS I, RO-0098557 , AK-1820 fast track designation QIDP ORPHAN DRUG EU 1-{(2R,3R)-3-[4-(4-cyanophenyl)-1,3- thiazol-2-yl]-2-(2,5-difluoro-phenyl)-2-hydroxybutyl}-4-[(1RS)-1-({methyl[3-({[(methylamino)acetyl] oxy}methyl) pyridin-2-yl]carbamoyl}oxy)ethyl]-1H-1,2,4-triazol-4-ium monosulfate (IUPAC), corresponding to the molecular formula …