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Is Europe putting cancer research at risk?

25-07-2014

The European Society for Medical Oncology (ESMO) has expressed concern that the proposed European Union…

EuropeOncologyPharmaceuticalRegulationResearch

FDA approves Purdue’s abuse-deterrent opioid Targiniq ER for pain-management

FDA approves Purdue’s abuse-deterrent opioid Targiniq ER for pain-management

25-07-2014

The US Food and Drug Administration has approved privately-held USA-based Purdue Pharma’s abuse-deterrent…

AlcoholsAnalgesiaChemistryNaloxonePharmaceuticalPurdue PharmaRegulationTarginiqUSA

Sandoz application for biosimilar Neupogen accepted by US FDA

25-07-2014

The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarzio

GSK files EU regulatory submission for RTS,S malaria vaccine candidate

24-07-2014

UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

Levonorgestrel and ulipristal remain suitable emergency contraceptives, says EMA

24-07-2014

The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel…

EuropeLevonorgestrelNorLevoPharmaceuticalRegulationReproductiveulipristalWomen's Health

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

Biogen Idec’s Plegridy approved in Europe for relapsing-remitting multiple sclerosis

24-07-2014

US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable…

Biogen IdecCytokinesMultiple sclerosisNeurologicalPharmaceuticalPlegridyRegulationUSA

US FDA approves Gilead’s Zydelig for three types of blood cancers

24-07-2014

The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US…

BiotechnologyGilead SciencesidelalisibOncologyRegulationUSAZydelig

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

23-07-2014

The National Institute for Health and Care Excellence (NICE), the UK’s health care guidance body, has…

Acute coronary syndromesCardio-vascularEfientEli LillyPharmaceuticalprasugrelRegulationUK

NICE recommends Amitiza to treat long-term, painful constipation

NICE recommends Amitiza to treat long-term, painful constipation

23-07-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Amitiza (lubiprostone)…

AmitizaGastro-intestinalsGastroenterologyPharmaceuticalRegulationSucampoUK

UK’s NICE recommends Xtandi and Yervoy under patient access schemes

UK’s NICE recommends Xtandi and Yervoy under patient access schemes

23-07-2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued guidance recommending…

Astellas PharmaBristol-Myers SquibbOncologyPharmaceuticalRegulationUKXtandiYervoy

Novasep sites approved by US FDA

Novasep sites approved by US FDA

22-07-2014

French active ngredients company Novasep has successfully completed US Food and Drug Administration pre-approval…

Active pharmaceutical ingredientFranceNovasepPharmaceuticalRegulationUSA

New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review

New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review

21-07-2014

The organization that reviews oncology medicines in Canada may unnecessarily delay approvals while cancer…

BevacizumabCanadaFraser InstituteOncologyPharmaceuticalRegulation

ABPI and Bioindustry Association team up to improve biosimilar understanding

ABPI and Bioindustry Association team up to improve biosimilar understanding

21-07-2014

The Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have…

Association of the British Pharmaceutical IndustryBiosimilarsRegulationUK

Australian Health Ministers sign on to end HIV transmissions by 2020

Australian Health Ministers sign on to end HIV transmissions by 2020

21-07-2014

All Australian Health Ministers have committed to working towards the virtual elimination of new Australian…

AIDSAnti-viralsAustraliaHealthcareHIV/AIDSPharmaceuticalPoliticsRegulation

US breakthrough status for InterMune’s pirfenidone

US breakthrough status for InterMune’s pirfenidone

21-07-2014

US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation…

BiotechnologyEsbrietFood and Drug AdministrationInterMunepirfenidoneRare diseasesRegulationRespiratory and PulmonaryUSA

Ireland to make more drugs available over the counter

Ireland to make more drugs available over the counter

20-07-2014

Last week, Ireland’s Health Products Regulatory Authority (HPRA) published a list of 12 active substances…

Health Products Regulatory AuthorityIrelandPharmaceuticalRegulation

Harmonizing drugs standards in West Africa

Harmonizing drugs standards in West Africa

18-07-2014

The recent decision by the heads of National Medicine Regulatory Authorities (NMRA) and West African…

AfricaPharmaceuticalRegulationRest of the World

Pharming and Salix gain US approval for Ruconest

Pharming and Salix gain US approval for Ruconest

17-07-2014

Netherlands-based Pharming Group and Salix Pharmaceuticals have received approval from the US Food and…

BiotechnologyPharmingRare diseasesRegulationRuconestSalix PharmaceuticalsUSA

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