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PTC launches Translarna for DMD in Germany

PTC launches Translarna for DMD in Germany

03-12-2014

US biotech company PTC Therapeutics has announced that Translarna (ataluren) is commercially available…

CNS DiseasesGermanyMarkets & MarketingPharmaceuticalPTC TherapeuticsTranslarna

Novartis’ fingolimod fails to meet endpoint in primary progressive multiple sclerosis study

Novartis’ fingolimod fails to meet endpoint in primary progressive multiple sclerosis study

01-12-2014

Swiss drug major Novartis’ has announced that its Phase III INFORMS study in primary progressive multiple…

CNS DiseasesfingolimodGilenyaNovartisPharmaceuticalResearchSwitzerland

FDA adds warning to Tecfidera label after patient death

FDA adds warning to Tecfidera label after patient death

26-11-2014

The US Food and Drug Administration has issued a warning that a patient with multiple sclerosis who was…

Biogen IdecCNS DiseasesPharmaceuticalRegulationTecfideraUSA

Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy

Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy

28-10-2014

Rare and infectious disease specialist Sarepta provided an update on its discussions with the US Food…

CNS DiseaseseteplirsenPharmaceuticalRegulationSarepta TherapeuticsUSA

GW Pharmaceuticals granted orphan designation by the EMA for Epidiolex

GW Pharmaceuticals granted orphan designation by the EMA for Epidiolex

22-10-2014

Cannabinoid product specialist GW Pharmaceuticals has been granted orphan designation by the European…

CNS DiseasesepidiolexGW PharmaceuticalsPharmaceuticalResearchUSA

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

20-10-2014

Japanese drug major Eisai has had a supplemental New Drug Application for its in-house-discovered AMPA…

CNS DiseasesEisaiFycompaJapanPharmaceuticalRegulation

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

24-09-2014

The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment…

CNS DiseasesLundbeckOtsukaPharmaceuticalRegulationUSA

PTC Therapeutics establishes international headquarters in Dublin, appoints Adrian Haigh head of EMEA

PTC Therapeutics establishes international headquarters in Dublin, appoints Adrian Haigh head of EMEA

17-09-2014

USA-based PTC Therapeutics is to expand its global presence by adding key executives to leadership positions…

BoardroomCNS DiseasesIrelandPharmaceuticalPTC TherapeuticsTranslarna

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