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FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases

30-04-2012

USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued…

AmgenBiotechnologyNorth AmericaOncologyRegulationXgeva

US FDA backs new indications for Votrient and Afinitor

29-04-2012

The US Food and Drug Administration last week gave its approval for new indications for currently marketed…

AfinitorGlaxoSmithKlineNorth AmericaNovartisOncologyPharmaceuticalRegulationVotrient

US FDA again delays action on Takeda's alogliptin diabetes drug

26-04-2012

Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has received a complete response…

ActosalogliptinDiabetesNorth AmericaPharmaceuticalRegulationTakeda Pharmaceuticals

First Cushing's drug, Novartis' Signifor, approved in the EU

25-04-2012

The European Commission has approved Swiss drug major Novartis' (NOVN: VX) Signifor (pasireotide) for…

EuropeNovartisOncologyPharmaceuticalRare diseasesRegulationSignifor

FDA extends review of Ironwood and Forest's linaclotide to September

24-04-2012

The US Food and Drug Administration has told USA-based drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD)…

Forest LaboratoriesGastro-intestinalsIronwood PharmaceuticalslinaclotideNorth AmericaPharmaceuticalRegulation

Canada's drug review process needs enhancements, says diabetes charity

24-04-2012

According to a new report by the charity the Canadian Diabetes Association, despite improvements to Canada's…

North AmericaPharmaceuticalRegulation

FDA strengthens monitoring of post-approval drug safety

23-04-2012

In what is seen as a response to criticism that the agency lacks teeth in monitoring drugs once they…

BiotechnologyMarkets & MarketingNorth AmericaPharmaceuticalRegulation

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal

23-04-2012

Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Crucial need for global development of biosimilars, says head of European generics group

20-04-2012

"The need for a framework which allows global biosimilars development is now crucial," argued European…

BiotechnologyGenericsGlobalRegulation

US Senators Burr and Coburn introduce legislation to reform FDA

19-04-2012

US Senators Richard Burr (Republican, North Carolina) and Tom Coburn (Republican, Oklahoma) this week…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

Leahy Bill would boost generic drug safety in USA, says consumer group

19-04-2012

A bill giving generic drug manufacturers in the USA the authority to revise labeling for their products…

GenericsNorth AmericaPoliticsRegulation

PhRMA welcomes US Congressional support for Pediatric Reauthorization ACT

19-04-2012

US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has welcomed the bipartisan…

LegalNorth AmericaPharmaceuticalRegulation

Towards a robust global framework for conduct and oversight of clinical trials in EU

18-04-2012

The European Medicines Agency has published the final reflection paper on ethical and good clinical practice…

BiotechnologyEuropePharmaceuticalRegulationResearch

NICE turns down Roche breast cancer drug Avastin, citing too many uncertainties

18-04-2012

UK drug watchdog the National Institute for Health and Clinical Excellence (NICE), said this morning…

AvastinEuropeOncologyPharmaceuticalPricingRegulationRoche

Halozyme plunges as FDA call for more data on HyQ BLA

17-04-2012

USA-based Halozyme Therapeutics saw its shares plummet 24% to $8.56 by close of trading yesterday, after…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQImmunologicalsNorth AmericaRegulation

No proof of added benefit of Sativex, says German IQWiG

17-04-2012

In an early benefit assessment under to the German Act on the Reform of the Market for Medicinal Products…

AlmirallEuropeGW PharmaceuticalsNeurologicalPharmaceuticalPricingRegulationSativex

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