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Alcon’s Simbrinza approved for glaucoma in the EU

Alcon’s Simbrinza approved for glaucoma in the EU

28-07-2014

Eyecare specialist Alcon, a division of Swiss drug major Novartis, says its Simbrinza eye drops suspension…

AlconEuropeEuropean CommissionGlaucomaOphthalmicsPharmaceuticalRegulationSimbrinza

AcelRx Pharma’s Zalviso approval delayed by FDA

AcelRx Pharma’s Zalviso approval delayed by FDA

28-07-2014

USA-based specialty pharma firm AcelRx Pharmaceuticals says that the US Food and Drug Administration…

AcelRxFood and Drug AdministrationNeurologicalPharmaceuticalRegulationUSAZalviso

Xultophy, Accofil and Busulfan recommended by EMA/CHMP

26-07-2014

At its July 2014 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human…

AccofilAccord HealthcareBiosimilarsBusulfanDiabetesEuropeFresenius KabiImmunologicalsNovo NordiskOncologyPharmaceuticalRegulationXultophy

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

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

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

24-07-2014

German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’…

Boehringer IngelheimDabigatranGermanyHematologyPharmaceuticalPradaxaPyridinesRegulationUKUniversity of California

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

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

22-07-2014

US-based pharmaceutical company Halozyme Therapeutics has said it is once again enrolling and dosing…

Halozyme TherapeuticsHyaluronidaseOncologyPancreatic cancerPEGylationPharmaceuticalRegulationUSA

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

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

22-07-2014

In the latest in an ongoing takeover attempt of Allergan by Valeant, Valeant has contacted financial…

AllerganBausch & LombCanadaFinancialPharmaceuticalRegulationUSAValeant Pharmaceuticals

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

21-07-2014

USA-based Arena Pharmaceuticals has entered into an exclusive marketing and supply agreement for its…

AbicArena PharmaceuticalsBelviqLicensingMetabolicsObesityPharmaceuticalRegulationRest of the WorldTeva Pharmaceutical Industries

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

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

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

US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

16-07-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has today published the results…

Breast cancerGermanyInstitute for Quality and Efficiency in Health CareOncologyPharmaceuticalRegulation

CellAct Pharma receives orphan drug designation in EU for cancer drug

CellAct Pharma receives orphan drug designation in EU for cancer drug

16-07-2014

The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists…

CAP7.1CellAct PharmaEuropeGermanyHepatologyOncologyPharmaceuticalRegulationTreatment of biliary tract cancers

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