Regulation - Pharmaceutical, Neurological

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US and EU regulatory filings for UCB’s antiepileptic brivaracetam

US and EU regulatory filings for UCB’s antiepileptic brivaracetam

21-01-2015

Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European…

BRIVARACETAMEuropeNeurologicalPharmaceuticalRegulationUCBUSA

US FTC approves final order preserving in nicotine patches market competition

US FTC approves final order preserving in nicotine patches market competition

21-01-2015

Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling…

GlaxoSmithKlineHabitrolMergers & AcquisitionsNeurologicalNovartisPharmaceuticalRegulationUSA

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

FDA approves Fresenius Kabi’s neostigmine methylsulfate injection

20-01-2015

Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group, has received approval from the US…

FreseniusFresenius Kabineostigmine methylsulfateNeurologicalPharmaceuticalRegulationUSA

US FDA approves AbbVie’s Duopa for Parkinson’s disease

US FDA approves AbbVie’s Duopa for Parkinson’s disease

13-01-2015

The US Food and Drug Administration has approved US drugmaker AbbVie’s Duopa (carbidopa and levodopa)…

AbbVieCarbidopa-LevodopaNeurologicalPharmaceuticalRegulationUSA

CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

CHMP recommends approval of Newron/Zambon's Xadago for Parkinson's disease

07-01-2015

Italy-based Newron Pharmaceuticals and its partner Zambon have received a recommendation from the Euroean…

ItalyNeurologicalNewron PharmaceuticalsPharmaceuticalRegulationXadagoZambon

Hospira gains US FDA backing for non-opioid analgesic Dyloject

Hospira gains US FDA backing for non-opioid analgesic Dyloject

31-12-2014

US injectable drugs and infusion technologies specialist Hospira has received approval from the US Food…

DylojectHospiraNeurologicalPharmaceuticalRegulationUSA

Sumitomo Dainippon’s lurasidone meets primary endpoint in Ph III study

30-12-2014

Japanese drug major Sumitomo Dainippon Pharma has released positive preliminary findings from a Phase…

Dainippon Sumitomo PharmaJapanLatudalurasidoneNeurologicalPharmaceuticalRegulationResearch

Takeda gains approval for Takecab in Japan; files MS drug NDA

Takeda gains approval for Takecab in Japan; files MS drug NDA

29-12-2014

Japan’s largest drugmaker Takeda Pharmaceutical and partner Otsuka Pharmaceuticals have been granted…

Gastro-intestinalsGlatiramer AcetateJapanNeurologicalOtsuka PharmaceuticalsPharmaceuticalRegulationTakecabTakeda PharmaceuticalTeva Pharmaceuticals Industriesvonoprazan

Newron and Zambon re-submit NDA for safinamide following Refusal to File

Newron and Zambon re-submit NDA for safinamide following Refusal to File

29-12-2014

Clinical-stage biopharma company Newron and its commercial development partner, fellow Italy-based pharma…

NeurologicalNewron PharmaPharmaceuticalRegulationsafinamideUSAZambon

FDA backs Actavis’ Namzaric, but issues CRL on nebivolol/valsartan combo

FDA backs Actavis’ Namzaric, but issues CRL on nebivolol/valsartan combo

26-12-2014

The US Food and Drug Administration has approved the New Drug Application for Namzaric (formerly known…

ActavisAdamas PharmaceuticalsCardio-vasculardonepezilMemantine HCLNamzaricnebivololNeurologicalPharmaceuticalRegulationUSAvalsartan

US FDA issues warning on Pfizer’s Geodon

US FDA issues warning on Pfizer’s Geodon

11-12-2014

The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under…

GeodonNeurologicalPfizerPharmaceuticalRegulationUSAZiprasidone

Labeling update of Lundbeck and Otsuka’s Abilify Maintena approved by FDA

08-12-2014

The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for…

Abilify MaintenaLundbeckNeurologicalOtsuka PharmaceuticalPharmaceuticalRegulationUSA

Added benefit of Lundbeck’s Selincro not proven, says IQWiG

04-12-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment…

GermanyLundbeckNeurologicalPharmaceuticalPricingRegulationSelincro

Ipsen’s Dysport accepted for review by US FDA

Ipsen’s Dysport accepted for review by US FDA

28-11-2014

French drugmaker Ipsen says that the US Food and Drug Administration has accepted for review its supplemental…

DysportIpsenNeurologicalPharmaceuticalRegulationUSA

UK's NICE recommends Selincro to help reduce alcohol dependence

UK's NICE recommends Selincro to help reduce alcohol dependence

26-11-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Selincro (nalmefene)…

LundbeckNeurologicalPharmaceuticalRegulationSelincroUK

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

13-11-2014

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationUSA

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

13-11-2014

Ireland-headquartered generics major Actavis has had its Supplemental New Drug Application for Saphris…

ActavisIrelandNeurologicalPharmaceuticalRegulationSaphris

Highlights of EMA Pharmacovigilance unit meeting

09-11-2014

At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee…

BayerBiogen IdecCSL BehringEuropeHelixateHematologyKogenateNeurologicalPharmaceuticalRegulationTecfidera

Eisai “dismayed” by G-BA decision on Fycompa

06-11-2014

Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee…

EisaiFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Sarepta will rebound strongly from eteplirsen US delay, says analyst

06-11-2014

US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationSarepta TherapeuticsUSA

CNS drugs development takes longer than other drugs, says Tufts CSDD

05-11-2014

Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are…

NeurologicalPharmaceuticalRegulationResearchUSA

Eisai's Fycompa launches in Australia for seizures

Eisai's Fycompa launches in Australia for seizures

03-11-2014

Fycompa (perampanel), manufactured by Japanese drug major Eisai, has been approved for reimbursement…

AustraliaEisaiFycompaNeurologicalPharmaceuticalRegulation

US FDA reveals discussions with Sarepta over eteplirsen

US FDA reveals discussions with Sarepta over eteplirsen

31-10-2014

In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationResearchSarepta TherapeuticsUSA

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