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Sigma-Tau gains US FDA approval for orphan eye drug Cystaran

09-10-2012

The US subsidiary of privately-owned Italian drugmaker Sigma-Tau says it has received approval from the…

CystaranNorth AmericaOphthalmicsPharmaceuticalRegulationSigma Tau

Kyowa Hakko files for additional indications for Leunase

08-10-2012

Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) says that it has filed an application based on evidence…

Asia-PacificKyowa Hakko KirinLeunaseOncologyPharmaceuticalRegulation

Industry and government cooperate to stimulate biotech clinical trials in Italy

08-10-2012

In Italy last week, the Director General of AIFA (Agenzia Italiana del Farmaco) Luca Pani, the president…

BiotechnologyEuropeRegulationResearch

UK's NICE draft guidance backs NHS use of Lucentis in DME

05-10-2012

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in new draft guidance…

BiotechnologyEuropeLucentisNovartisOphthalmicsPharmaceuticalPricingRegulation

New US bill would provide exclusivity add-on for significant drug combos

04-10-2012

Legislation co-sponsored in the USA by Representatives Brian Bilbray (Republican, California), Carolyn…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulation

New Canadian rare disease strategy welcomed as offering hope and solutions for patients

04-10-2012

The Canadian government this week announced a new national framework to improve access to "orphan drugs"…

BiotechnologyNorth AmericaPharmaceuticalRare diseasesRegulationResearch

European Commission looks for feedback on pediatric regulation experience

04-10-2012

The European Commission has launched a public consultation on the experience gained with the paediatric…

BiotechnologyEuropePharmaceuticalRegulationResearch

USA's PDUFA V sets new course for regulatory science, say BIO and PhRMA

02-10-2012

With the implementation of the USA's Prescription Drug User Fee Act (PDUFA V) on Monday, trade groups…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

Proposal in relation to Actelion's Tracleer in New Zealand

01-10-2012

New Zealand's national pharmaceuticals funding agency PHARMAC is seeking feedback on a proposal in relation…

ActelionAsia-PacificBiotechnologyPricingRegulationRespiratory and PulmonaryTracleer

Protalix gains Israeli approval for Gaucher drug Elelyso

01-10-2012

ael-based Protalix BioTherapeutics (NYSE-AMEX: OLX) has received marketing authorization from the Israeli…

BiotechnologyElelysoPharmaceuticalProtalix BioTherapeuticsRare diseasesRegulationRest of the World

Abbott's Humira gets FDA backing for new use

30-09-2012

US health care major Abbott Laboratories (NYSE: ABT) says that the US Food and Drug Administration has…

Abbott LaboratoriesGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

Early FDA approval for Bayer's Stivarga in advanced colorectal cancer

28-09-2012

Bayer said Stivarga will be ready for distribution as soon as today (September 28 and set a wholesale…

BayerNorth AmericaOncologyPharmaceuticalregorafenibRegulationStivarga

FDA sets March 2013 PDUFA date for re-submitted Eliquis

28-09-2012

The US Food and Drug Administration has acknowledged receipt of the New Drug Application resubmission…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulation

Novartis criticizes system of public procurement tenders in Russia

28-09-2012

Amid the ever growing competition in the Russian pharmaceutical market, the world's largest pharmaceutical…

EuropeNovartisPharmaceuticalPricingRegulation

2176 to 2200 of 2733 results

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