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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

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

NICE recommends Biogen Idec’s Tecfidera for multiple sclerosis

NICE recommends Biogen Idec’s Tecfidera for multiple sclerosis

27-08-2014

The UK’s drugs watch dog, the National Institute for Health and Care Excellence (NICE), has recommended…

Biogen IdecBiotechnologyCNS DiseasesMultiple sclerosisRegulationTecfideraUK

US FDA grants Edison Pharmaceuticals’ EPI-743 orphan status for Leigh Syndrome

US FDA grants Edison Pharmaceuticals’ EPI-743 orphan status for Leigh Syndrome

09-06-2014

The US Food and Drug Administration has granted orphan drug status to privately-held US pharma company…

CNS DiseasesEdison PharmaceuticalsEPI-743PharmaceuticalRegulationUSA

NICE asks Biogen Idec for more information on Tecfidera

NICE asks Biogen Idec for more information on Tecfidera

21-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is calling on US biotech firm Biogen…

Biogen IdecBiotechnologyCNS DiseasesRegulationTecfideraUK

Sativex approved for MS in Switzerland

Sativex approved for MS in Switzerland

27-11-2013

UK-based GW Pharmaceuticals (AIM: GWP), which is focused on novel cannaboid therapeutics, has received…

AlmirallCNS DiseasesEuropeGW PharmaceuticalsPharmaceuticalRegulationSativex

Sanofi’s Lemtrada gets support from FDA advisory panel

Sanofi’s Lemtrada gets support from FDA advisory panel

14-11-2013

French drug major Sanofi (Euronext: SAN) has received support from a US Food and Drug Administration…

CNS DiseasesEuropeGenzymeLemtradaPharmaceuticalRegulationSanofi

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