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Health Canada issues import ban from three Indian drug plants

Health Canada issues import ban from three Indian drug plants

01-10-2014

Regulator Health Canada has taken action to stop the imports from three Indian manufacturing sites.

Apotex Research Private LimitedCanadaIndiaIpca LaboratoriesPharmaceuticalRegulation

Salix and Progenics receive FDA approval for Relistor injection for opioid-induced constipation

Salix and Progenics receive FDA approval for Relistor injection for opioid-induced constipation

01-10-2014

Gastrointestinal specialist Salix Pharmaceuticals and Progenix Pharmaceuticals have had their Relistor…

Gastro-intestinalsPharmaceuticalProgenics PharmaceuticalsRegulationRelistorSalix PharmaceuticalsUSA

Diplomat pharmacy receives expanded FDA approval for Xtandi in metastatic prostate cancer

Diplomat pharmacy receives expanded FDA approval for Xtandi in metastatic prostate cancer

01-10-2014

Japanese drug major Astellas Pharma and Medivation has received extended approval for Xtandi (enzalutamide)…

Astellas PharmaDiplomatMedivationOncologyPharmaceuticalRegulationUSAXtandi

Innovative and orphan drugs to become more accessible in Russia

30-09-2014

The Russian Parliament (State Duma) plans to ease access to innovative and orphan drugs to the Russian…

PharmaceuticalRegulationResearchRussia

Bristol-Myers Squibb updates on Opdivo regulatory milestones

30-09-2014

US pharma major Bristol-Myers Squibb has announced multiple regulatory milestones for Opdivo (nivolumab),…

Bristol-Myers SquibbEuropeOncologyOno PharmaceuticalOpdivoPharmaceuticalRegulationUSA

ESMO 2014: Canada and Europe sometimes years slower than USA in approving cancer

ESMO 2014: Canada and Europe sometimes years slower than USA in approving cancer

29-09-2014

Access to potentially life-extending cancer drugs varies significantly in different regions of the world,…

CanadaEastern EuropeEuropeOncologyPharmaceuticalRegulationUSA

Added indication for Daiichi Sankyo’s Lixiana in Japan

Added indication for Daiichi Sankyo’s Lixiana in Japan

29-09-2014

The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi…

Cardio-vascularDaiichi SankyoJapanLixianaPharmaceuticalRegulation

US FDA approves Iluvien for diabetic macular edema

US FDA approves Iluvien for diabetic macular edema

28-09-2014

US ophthalmic drug specialist Alimera Sciences says that the US Food and Drug Administration has approved…

Alimera SciencesIluvienMedidurOphthalmicsPharmaceuticalpSividaRegulationTethadurUSA

EMA committee launches pilot project to consult patients on benefits and risk of medicines

EMA committee launches pilot project to consult patients on benefits and risk of medicines

26-09-2014

The European Medicines Agency has launched a pilot project to involve patients in the assessment of the…

Committee for Medicine Products for Human UseEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

Almirall’s aclidinium bromide/formoterol backed by EMA/CHMP to treat COPD

26-09-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a…

aclidiniumAlmirallAstraZenecaBrimica GenuairDuaklir GenuairEuropeformoterolPharmaceuticalRegulationRespiratory and Pulmonary

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

25-09-2014

German family-owned pharma major Boehringer Ingelheim Pharmaceuticals has received US Food and Drug Administration…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivaUSA

AbbVie's Humira gains added indication from US FDA

AbbVie's Humira gains added indication from US FDA

25-09-2014

The US Food and Drug Administration has approved US drugmaker AbbVie’s Humira (adalimumab) for reducing…

AbbVieGastro-intestinalsHumiraInflammatory diseasesPharmaceuticalRegulationUSA

FDA warning letters rise 78% over six years with increase expected in 2015

FDA warning letters rise 78% over six years with increase expected in 2015

25-09-2014

The number of warning letters sent by the US Food and Drug Administration increased substantially by…

PharmaceuticalRegulationUSA

NICE opens consultation on three drugs for chronic bowel condition

NICE opens consultation on three drugs for chronic bowel condition

24-09-2014

Three drugs to treat ulcerative colitis, a chronic bowel condition, have not been proven to be more cost…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalPricingRegulationRemicadeSimponi InjectionUK

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

24-09-2014

The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment…

CNS DiseasesLundbeckOtsukaPharmaceuticalRegulationUSA

Tekmira shares jump as US FDA and Health Canada expand access to Ebola drug

Tekmira shares jump as US FDA and Health Canada expand access to Ebola drug

23-09-2014

Shares of Tekmira Pharmaceuticals have rocketed after the US Food and Drug Administration authorized…

Antibiotics and Infectious diseasesCanadaEbolaFDAHealthPharmaceuticalRegulationTekmira PharmaceuticalsTKM-EbolaUSA

Despite limited size, Chile's pharma market offers growing opportunity

23-09-2014

By the end of 2014, the Chilean pharmaceutical market is expected to be worth $2 billion, increasing…

ChileHealthcareMarkets & MarketingPatentsPharmaceuticalRegulation

OxThera’s Oxabact gains orphan drug designation in EU

OxThera’s Oxabact gains orphan drug designation in EU

23-09-2014

Privately-held Swedish biopharmaceutical company OxThera AB’s product Oxabact (oxalobacter formigenes)…

EUGastro-intestinalsOxabactOxTheraPharmaceuticalRegulationSweden

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

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