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Positive FDA panel recommendation for Vanda’s tasimelteon

Positive FDA panel recommendation for Vanda’s tasimelteon


The US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee…

HetliozNorth AmericaOphthalmicsPharmaceuticalRegulationtasimelteonVanda Pharmaceuticals

Aegerion gains European approval for rare disease drug


The European Commission has approved US biopharma company Aegerion Pharmaceuticals' (Nasdaq: AEGR) Lojuxta…

Aegerion PharmaceuticalsBiotechnologyCardio-vascularEuropeJuxtapidKynamroLojuxtalomitapidePharmaceuticalRare diseasesRegulation

Vanda Pharma pulls EU application for schizophrenia drug candidate Fanaptum


The European Medicines Agency has been formally notified by USA-based Vanda Pharmaceuticals (Nasdaq:…

EuropeFanaptumNeurologicalPharmaceuticalRegulationVanda Pharmaceuticals

FDA clears Sanofi and Isis' Kynamro for inherited cholesterol disorder


The US Food and Drug Administration yesterday approved Sanofi (Euronext: SAN) subsidiary Genzyme's orphan…

BiotechnologyCardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

Vanda's tasimelteon meets primary endpoint in Ph III study


Shares of USA-based Vanda Pharmaceuticals (Nasdaq: VNDA) moved 2.8% higher to $3.22 in early trading…

NeurologicalPharmaceuticalResearchtasimelteonVanda Pharmaceuticals

Makers of Kynamro and Fanaptum to appeal negative CHMP opinions


French drug major Sanofi's (Euronext: SAN) subsidiary Genzyme and US partner Isis Pharmaceuticals (Nasdaq:…

BiotechnologyEuropeFanaptFanaptumGenzymeIsis PharmaceuticalsKynamroNeurologicalPharmaceuticalRare diseasesRegulationSanofiVanda Pharmaceuticals

FDA advisory panel votes 9 to 6 to approve Genzyme's Kynamro


The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory yesterday voted by…

BiotechnologyCardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

Isis earns $25 million milestone from Genzyme as US FDA accepts Kynamro NDA


The US Food and Drug Administration has accepted for filing the New Drug Application for Kynamro (mipomersen…

BiotechnologyCardio-vascularFinancialGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRegulationSanofi

Vanda gains rights to Lilly's NK-1 receptor antagonist


USA-based Vanda Pharmaceuticals (Nasdaq: VNDA) said yesterday that it has acquired an exclusive worldwide…

Eli LillyLicensingNeurologicalPharmaceuticalVanda Pharmaceuticals

Genzyme and Isis file Kynamro NDA in USA


Biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN), has submitted a New Drug…

Cardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

Isis sees Kynamro delay; adds new drugs to pipeline


California, USA-based Isis Pharmaceuticals (Nasdaq: ISIS) announced yesterday that there will be a slight…

Cardio-vascularGenzymeIsis PharmaceuticalsKynamromipomersenNephrology and HepatologyPharmaceuticalRegulationResearchSanofi

Mochida diabetes deal with Merck; Vanda links with Megapharm


Japanese mid-sized drugmaker Mochida Pharmaceutical (TYO: 4534) saw its shares jump 5.8% to 900 yen,…

BiotechnologyDiabetesFanaptLicensingMegapharmMerck & CoMochida PharmaceuticalNeurologicalPharmaceuticalVanda Pharmaceuticals

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