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IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

19-02-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG), in an early benefit assessment…

Boehringer IngelheimGermanyGiotrifNorthern EuropeOncologyPharmaceuticalPricingRegulation

AHF claims victory over FDA on Gilead’s PrEP

19-02-2014

The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs

FDA initiates the Secure Supply Chain Pilot Program to enhance security of imported drugs

19-02-2014

The US Food and Drug Administration is initiating a Secure Supply Chain Pilot Program to enhance the…

PharmaceuticalRegulationUSA

FDA approves Northera for neurogenic orthostatic hypotension

FDA approves Northera for neurogenic orthostatic hypotension

19-02-2014

Shares of US biotech firm Chelsea Therapeutics soared 38% to $6.75 in after-hours trading yesterday,…

BiotechnologyChelsea TherapeuticsDainippon Sumitomo PharmaNorth AmericaNortheraRare diseasesRegulationUSA

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

FDA concludes Indian visit with pledge to focus on quality

FDA concludes Indian visit with pledge to focus on quality

18-02-2014

The US Food and Drug Administration’s visit to India concluded with roundtable meetings organized by…

IndiaPharmaceuticalRegulation

Call for EU regulators to get tougher on pediatric clinical trials for cancer drugs

Call for EU regulators to get tougher on pediatric clinical trials for cancer drugs

18-02-2014

Children with cancer are being denied potentially life-saving drugs because European Union rules are…

EuropeOncologyPharmaceuticalRegulation

European experts criticize the Drugs Act; focus on Bulgarian drug shortages

17-02-2014

European experts have claimed as unlawful the measures introduced by the amendments to the Act for Medicinal…

EuropeMarkets & MarketingPharmaceuticalRegulation

Scancell granted orphan drug designation for melanoma drug

Scancell granted orphan drug designation for melanoma drug

17-02-2014

UK-based immunotherapy company Scancell has been granted orphan drug designation for its SCIB1 ImmunoBody…

ImmunologicalsOncologyPharmaceuticalRegulationScancellSCIB1UKUSA

FDA approves Vimizim to treat rare congenital enzyme disorder

FDA approves Vimizim to treat rare congenital enzyme disorder

17-02-2014

The US Food and Drug Administration on Friday (February 14) approved BioMarin Pharmaceutical’s Vimizim…

BioMarin PharmaceuticalNorth AmericaPharmaceuticalRare diseasesRegulationUSAVimizim

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

14-02-2014

Germany’s Bayer says it has successfully concluded the decentralized European registration procedure…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductive

Actelion’s Opsumit approved by SwissMedic for PAH patients

Actelion’s Opsumit approved by SwissMedic for PAH patients

14-02-2014

Swiss biotech firm Actelion announced today that SwissMedic has approved Opsumit (macitentan) for pulmonary…

ActelionBiotechnologyCardio-vascularNorthern EuropeOpsumitRegulation

Teva gains full FDA approval of CML drug Synribo

Teva gains full FDA approval of CML drug Synribo

14-02-2014

Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full…

North AmericaOncologyPharmaceuticalRegulationSynriboTeva Pharmaceutical IndustriesUSA

FDA says Durect’s pain relief drug Posidur needs additional safety studies

FDA says Durect’s pain relief drug Posidur needs additional safety studies

13-02-2014

US drugmaker Durect Corp says that the US Food and Drug Administration has issued a Complete Response…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

FDA advisory committee votes against approval of antiplatelet therapy cangrelor

FDA advisory committee votes against approval of antiplatelet therapy cangrelor

13-02-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted yesterday…

cangrelorCardio-vascularPharmaceuticalRegulationThe Medicines CompanyUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Health Canada approves Celgene’s Pomalyst for multiple myeloma

Health Canada approves Celgene’s Pomalyst for multiple myeloma

12-02-2014

Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide…

BiotechnologyCanadaCelgeneNorth AmericaOncologyPomalystRegulation

Sprout Pharmaceuticals to resubmit NDA for flibanserin

Sprout Pharmaceuticals to resubmit NDA for flibanserin

12-02-2014

US privately-held sexual health specialists Sprout Pharmaceuticals has received ‘clear guidance’…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

US FDA visit to India results in first Statement of Intent

US FDA visit to India results in first Statement of Intent

12-02-2014

A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family…

IndiaPharmaceuticalPoliticsRegulationUSA

UK’s NICE calls for more people at risk of CVD to be prescribed statins

UK’s NICE calls for more people at risk of CVD to be prescribed statins

12-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is recommending that many more people…

Cardio-vascularHealthcarePharmaceuticalRegulationUK

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

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