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First UK NICE highly specialized technologies guidance recommends Soliris

First UK NICE highly specialized technologies guidance recommends Soliris

28-01-2015

England’s health costs watchdog the National Institute for Health and care Excellence has today issued…

Alexion PharmaceuticalsBiotechnologyHematologyPricingRare diseasesRegulationSolarisUK

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 FDA approves Symplmed and Servier’s Prestalia

US FDA approves Symplmed and Servier’s Prestalia

27-01-2015

Privately-held US drugmaker Symplmed Pharmaceuticals says that the US Food and Drug Administration has…

Cardio-vascularPharmaceuticalPrestaliaRegulationServierSymplmedUSA

The FDA should innovate to respond to new health economy, says PwC survey

The FDA should innovate to respond to new health economy, says PwC survey

27-01-2015

Health care product manufacturers are now much more willing to have their products judged based on economic…

FDAFood and Drug AdministrationPharmaceuticalPwCRegulationUSA

US FDA approves first generic of AstraZeneca’s Nexium

US FDA approves first generic of AstraZeneca’s Nexium

27-01-2015

The US Food and Drug Administration yesterday approved a generic version of Nexium (esomeprazole), Anglo-Swedish…

AstraZenecaGastro-intestinalsGenericsNexiumRegulationTeva Pharmaceutcal IndustriesUSA

Rockwell's Triferic cleared for marketing by US FDA

26-01-2015

The US Food and Drug Administration has approved US biopharma company Rockwell Medical’s Triferic (ferric…

Nephrology and HepatologyPharmaceuticalRegulationRockwell MedicalTrifericUSA

Nicox holds successful pre-NDA meeting with FDA for AC-170

Nicox holds successful pre-NDA meeting with FDA for AC-170

26-01-2015

French ophthalmics company Nicox has held a positive pre-New Drug Application meeting with the US Food…

AC-170NicOxOphthalmicsPharmaceuticalRegulationUSA

ALK's partner Torii submits NDA in Japan for house dust mite sublingual tablet

ALK's partner Torii submits NDA in Japan for house dust mite sublingual tablet

26-01-2015

Denmark-based allergy specialist ALK Abello’s Japanese partner, Torii Pharmaceutical, has submitted…

ALK AbelloImmunologicalsJapanPharmaceuticalRegulationSLIT-tabletTorii Pharma

Novartis’ meningitis B vaccine Bexsero approved by US FDA

Novartis’ meningitis B vaccine Bexsero approved by US FDA

24-01-2015

On Friday, the US Food and Drug Administration granted accelerated approval of Swiss pharma giant Novartis’…

BexseroNovartisPharmaceuticalRegulationUSAVaccines

US FDA approves NPS Pharma’s Natpara

US FDA approves NPS Pharma’s Natpara

24-01-2015

The US Food and Drug Administration on Friday approved NPS Pharmaceuticals’ Natpara (parathyroid hormone)…

BiotechnologyNatparaNPS PharmaceuticalsRare diseasesRegulationShireUSA

EMA recommends suspending medicines over flawed studies at GVK Biosciences

EMA recommends suspending medicines over flawed studies at GVK Biosciences

23-01-2015

A number of medicines for which authorization in the European Union was primarily based on clinical studies…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

FDA's anti-infective committee recommends Astellas' Cresemba

FDA's anti-infective committee recommends Astellas' Cresemba

23-01-2015

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has voted unanimously…

Antibiotics and Infectious diseasesAstellasCresembaPharmaceuticalRegulationUSA

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

German Federal Joint Committee confirms 'considerable' benefit of Eisai's Halaven in breast cancer

23-01-2015

The German Federal Joint Committee has confirmed the ‘considerable’ additional benefit of Japanese…

EisaiGermanyHalavenOncologyPharmaceuticalRegulation

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

CHMP adopts positive opinion on expanding indication for Pfizer's Prevenar 13

23-01-2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive…

PfizerPharmaceuticalPrevenarRegulationRespiratory and Pulmonary

Novo Nordisk gets positive opinion for Saxenda from EMA’s CHMP

Novo Nordisk gets positive opinion for Saxenda from EMA’s CHMP

23-01-2015

Danish diabetes care giant Novo Nordisk revealed yesterday that the European Medicines Agency’s Committee…

DiabetesEuropeMetabolicsNovo NordiskPharmaceuticalRegulationSaxenda

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

23-01-2015

The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England,…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

NICE set to recommend Boehringer’s type 2 diabetes drug Jardiance

NICE set to recommend Boehringer’s type 2 diabetes drug Jardiance

22-01-2015

England’s health care costs watchdog the National Institute for Health and Care Excellence (NICE) has…

Boehringer IngelheimDiabetesJardiancePharmaceuticalPricingRegulationUK

EMA publishes guide for pharma companies to support new medicines monitoring standard

EMA publishes guide for pharma companies to support new medicines monitoring standard

22-01-2015

The European Medicines Agency has published its guide to support the implementation of a new international…

EMAEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

22-01-2015

French drug major Sanofi and its subsidiary Genzyme have been granted marketing authorization by the…

BiotechnologyCerdelgaGeneticsGenzymeRegulationSanofi

AstraZeneca files marketing authorization application with EMA for lesinurad

AstraZeneca files marketing authorization application with EMA for lesinurad

22-01-2015

The European Medicines Agency has accepted the marketing authorization application by AstraZeneca for…

AstraZenecaGastro-intestinalslesinuradPharmaceuticalRegulation

Latest approval for Novartis’ Cosentyx, from US FDA

Latest approval for Novartis’ Cosentyx, from US FDA

22-01-2015

Adding to recent marketing clearances in Japan and the European Union, the US Food and Drug Administration…

BiotechnologyCosentyxDermatologicalsNovartisRegulationUSA

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