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Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

05-09-2014

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s…

KeytrudaMerck & CoOncologypembrolizumabPharmaceuticalRegulationUSA

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

FDA accepts Actavis NDA for eluxadoline

FDA accepts Actavis NDA for eluxadoline

03-09-2014

Ireland-headquartered generic drug major Actavis says that the US Food and Drug Administration has accepted…

ActaviseluxadolineForest LaboratoriesFuriex PharmaceuticalsGastro-intestinalsPharmaceuticalRegulationUSA

FDA Breakthrough designation for ACADIA’s Nuplazid for Parkinson’s disease psychosis

FDA Breakthrough designation for ACADIA’s Nuplazid for Parkinson’s disease psychosis

03-09-2014

US biotech firm ACADIA Pharmaceuticals says that the US Food and Drug Administration has granted Breakthrough…

ACADIA PharmaceuticalsBiotechnologyNeurologicalNuplazidpimavanserinRegulationUSA

Bristol-Myers Squibb launches Daklinza in the UK for chronic hepatitis C

Bristol-Myers Squibb launches Daklinza in the UK for chronic hepatitis C

03-09-2014

US drug major Bristol-Myers Squibb has launched Daklinza (daclastavir) in the UK for chronic hepatitis…

AntiviralsBristol-Myers SquibbDaklinzaHepatitis CNephrology and HepatologyPharmaceuticalRegulationUK

Allergan’s Ozurdex approved for DME in Europe

Allergan’s Ozurdex approved for DME in Europe

02-09-2014

Allergan revealed today that the European Commission has extended the marketing authorization for Ozurdex…

AllerganEuropeOphthalmicsOzurdexPharmaceuticalRegulation

Australia participating in EU DCP for evaluation of generic drugs

Australia participating in EU DCP for evaluation of generic drugs

02-09-2014

Under the auspices of the International Generic Drug Regulators Pilot , Australia’s Therapeutic Goods…

AustraliaGenericsRegulation

New EMA guidance on EU periodic-safety-update-report single assessment for nationally authorized medicines

01-09-2014

The European Medicines Agency has updated its procedural guidance to ensure that marketing-authorization…

EuropePharmaceuticalRegulation

FDA backs added use for UCB’s Vimpat

01-09-2014

Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a…

NeurologicalPharmaceuticalRegulationUCBUSAVimpat

Thrombogenics gets Spanish reimbursement approval for Jetrea

Thrombogenics gets Spanish reimbursement approval for Jetrea

01-09-2014

Ophthalmic specialist ThromboGenics has received reimbursement in Spain from the Spanish Ministry of…

AlconJetreaNon-steroidal anti-inflammatory drugsOphthalmicsPharmaceuticalRegulationSpainThromboGenics

Vifor reports positive results from Ferinject study for chronic heart failure

Vifor reports positive results from Ferinject study for chronic heart failure

01-09-2014

Switzerland-based iron specialist Vifor Pharma says its Ferinject (ferric carboxymaltose) has met its…

Cardio-vascularChronic heart failureFerinjectPharmaceuticalRegulationSwitzerlandVifor Pharma

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

31-08-2014

Swiss drug major Novartis on Saturday presented striking new data for its LZC696 heart drug at the European…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationResearch

FTC puts conditions on acquisition of Insight Pharma by Prestige Brands

29-08-2014

US firm Prestige Brands Holdings, the maker of Dramamine (dimenhydrinate), has agreed to divest assets…

Insight PharmaceuticalsMergers & AcquisitionsPharmaceuticalPrestige BrandsRegulationUSA

FDA approves Elelyso for pediatric use in Gaucher disease

FDA approves Elelyso for pediatric use in Gaucher disease

29-08-2014

The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa)…

ElelysoPfizerPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationUSA

Curious resilience of the $50,000-per-QALY threshold

28-08-2014

For more than two decades, the ratio of $50,000 per quality-adjusted life-year (QALY) gained by using…

HealthcarePharmaceuticalPricingRegulationUSA

Green Cross Neulapeg biosimilar approved in South Korea

28-08-2014

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing…

AmgenAsia-PacificBiosimilarsBiotechnologyGreen CrossNeulapegNeulastaOncologyRegulation

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