Regulation - Pharmaceutical, CNS Diseases

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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

Eisai submits marketing authorization to the EU for Fycompa in new seizure indication

Eisai submits marketing authorization to the EU for Fycompa in new seizure indication

20-08-2014

Japanese drug major Eisai has submitted a marketing authorization application to the European Commission…

BrainCNS DiseasesEisaiEpilepsyFycompaJapanPartial-onset seizuresPharmaceuticalPrimary generalized tonic-clonic seizuresRegulationSeizure types

PTC Therapeutics given conditional approval in EU for Translarna in muscular dystrophy

PTC Therapeutics given conditional approval in EU for Translarna in muscular dystrophy

04-08-2014

Biopharmaceutical company PTC Therapeutics has received conditional marketing authorization from the…

CNS DiseasesDiseaseDuchenne muscular dystrophyEuropeGenetic engineeringGeneticsMuscular dystrophyPharmaceuticalPTC TherapeuticsRegulationTranslarna

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

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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