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GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

21-02-2014

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

Anoro ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance Biopharma

Ukraine government reduces bureaucratic hurdles in domestic pharmaceutical market

Ukraine government reduces bureaucratic hurdles in domestic pharmaceutical market

20-02-2014

The Ukrainian government is reducing the number of bureaucratic hurdles in the domestic pharmaceutical…

Eastern EuropePharmaceuticalRegulationUkraine

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

20-02-2014

The US Food and Drug Administration and the European Medicines Agency have set-up a new “cluster”…

EuropeNorth AmericaPharmaceuticalRegulationUSA

FDA accepts The Medicines Company's NDA for oritavancin with priority review

FDA accepts The Medicines Company's NDA for oritavancin with priority review

19-02-2014

The US Food and Drug Administration has accepted the filing of The Medicines Company’s New Drug Application…

Antibiotics and Infectious diseasesNorth AmericaoritavancinPharmaceuticalRegulationThe Medicines CompanyUSA

UK’s MHRA accepts Shire’s Elvanse filing for ADHD in adults

UK’s MHRA accepts Shire’s Elvanse filing for ADHD in adults

19-02-2014

Ireland-headquartered drugmaker Shire has had an application for its once-daily attention deficit/hyperactivity…

ElvanseNeurologicalPharmaceuticalRegulationShire

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

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