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Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

NICE final draft guidance recommends Norgine's Targaxan

NICE final draft guidance recommends Norgine's Targaxan

19-02-2015

The UK’s National Institute for Health and Care Excellence has published its final draft guidance recommending…

Nephrology and HepatologyNeurologicalNorginePharmaceuticalRegulationTargaxanUK

UPDATE: FDA approves Eisai’s Lenvima for a type of thyroid cancer and expands use of Banzel

UPDATE: FDA approves Eisai’s Lenvima for a type of thyroid cancer and expands use of Banzel

14-02-2015

The US Food and Drug Administration on Friday granted approval for Japanese pharma major Eisai’s Lenvima…

BanzelEisailenvatinibLenvimaNeurologicalOncologyPharmaceuticalRare diseasesRegulationUSA

Tecfidera, first-line oral treatment for multiple sclerosis, approved in India

13-02-2015

US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for…

Biogen IdecBiotechnologyIndiaNeurologicalRegulationTecfidera

Shire’s Vyvanse first FDA-approved drug for binge eating

Shire’s Vyvanse first FDA-approved drug for binge eating

31-01-2015

The US Food and Drug Administration on Friday approved UK drugmaker Shire’s Vyvanse (lisdexamfetamine…

NeurologicalPharmaceuticalRegulationShireUSAVyvanse

Shire receives fast-track designation from FDA for SHP609 in Hunter syndrome

Shire receives fast-track designation from FDA for SHP609 in Hunter syndrome

27-01-2015

Ireland-headquartered drugmaker Shire has received fast-track designation from the US Food and Drug Administration…

NeurologicalPharmaceuticalRegulationShireSHP609

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

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

Supernus notified of Par Pharma ANDA filing for Trokendi XR generic

09-12-2014

US drugmaker Supernus Pharmaceuticals says that it has received a Paragraph IV Notice Letter from privately-held…

GenericsNeurologicalPar PharmaceuticalsPatentsRegulationSupernus PharmaceuticalsTrokendi XRUSA

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

Credit Suisse sees PTC Therapeutics as a top stock pick

05-12-2014

Credit Suisse has released a biotech research report from analysts Jason Kantor and Jeremiah Shepard…

BiotechnologyFinancialNeurologicalPTC TherapeuticsRare diseasesRegulationTranslarna

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

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