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Bristol-Myers’ hep C drug Daklinza approved in Europe

Bristol-Myers’ hep C drug Daklinza approved in Europe

27-08-2014

US pharma major Bristol-Myers Squibb says that the European Commission has approved Daklinza (daclatasvir),…

Anti-viralsBristol-Myers SquibbDaklinzaEuropeGilead SciencesPharmaceuticalRegulationSovaldi

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

New indications approved in EU for Bristol-Myers/Pfizer Eliquis

30-07-2014

The European Commission has approved US pharma majors Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban)…

Bristol-Myers SquibbCardio-vascularEliquisEuropePfizerPharmaceuticalRegulation

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

Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

07-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Daklinza (daclatasvir), a potent, pan-genotypic…

Anti-viralsBristol-Myers SquibbDaklinzaDaklinza+SunvepraJapanPharmaceuticalRegulationSunvepra

Six new drugs recommended for approval by EMA’s CHMP

Six new drugs recommended for approval by EMA’s CHMP

27-06-2014

At its end-June meetings, the European Medicines Agency’s Committee for Medicinal Products for Human…

AbasriaAnti-viralsBristol-Myers SquibbCardio-vascularDaklinzaDiabetesEli LillyEuropeFreseniusGE HealthcarePharmaceuticalRegulationTriumeqVelphoroVifor PharmaVizamyl

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

UK’s NICE says “Yes” to Bristol-Myers’ Yervoy

UK’s NICE says “Yes” to Bristol-Myers’ Yervoy

13-06-2014

People in England with advanced skin cancer should be able to receive ipilimumab as a first treatment…

Bristol-Myers SquibbOncologyPharmaceuticalPricingRegulationUKYervoy

Mylan launches generic Paraplatin Injection in USA

Mylan launches generic Paraplatin Injection in USA

09-06-2014

US generics major Mylan has launched carboplatin injection, 50mg/5ml, in multi-dose vials, which is the…

Bristol-Myers SquibbGenericsMarkets & MarketingMylanOncologyParaplatinRegulationUSA

Breakthrough designation for B-MS/AbbVie’s MM drug elotuzumab

19-05-2014

The US Food and Drug Administration has granted elotuzumab, an investigational humanized monoclonal antibody…

AbbVieBristol-Myers SquibbelotuzumabOncologyPharmaceuticalRegulationUSA

Bristol-Myers’ nivolumab receives US FDA Breakthrough Therapy designation for Hodgkin lymphoma

15-05-2014

The US Food and Drug Administration has granted US drug major Bristol-Myers Squibb’s investigational…

Bristol-Myers SquibbnivolumabOncologyPharmaceuticalRegulationUSA

EMA advisory committee backs addition for Eliquis SmPC

EMA advisory committee backs addition for Eliquis SmPC

02-05-2014

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

Bristol-Myers SquibbCardio-vascularEliquisPfizerPharmaceuticalRegulation

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

Bristol-Myers Squibb files for US approval of daclatasvir and asunaprevir for hepatitis C

07-04-2014

US pharma major Bristol-Myers Squibb has submitted New Drug Applications with the US Food and Drug Administration…

Anti-viralsasunaprevirBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

Added benefit for non-pre-treated Yervoy patients in advanced melanoma not proven, says IQWiG

Added benefit for non-pre-treated Yervoy patients in advanced melanoma not proven, says IQWiG

19-03-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit…

Bristol-Myers SquibbGermanyNorthern EuropeOncologyPharmaceuticalPricingRegulationYervoy

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

FDA approves new use for Bristol-Myers/Pfizer’ Eliquis

16-03-2014

The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New…

Bristol-Myers SquibbCardio-vascularEliquisNorth AmericaPfizerPharmaceuticalRegulationUSA

FDA approves Bydureon Pen for type 2 diabetes

FDA approves Bydureon Pen for type 2 diabetes

03-03-2014

Anglo-Swedish drug major AstraZeneca says the US Food and Drug Administration has approved the Bydureon…

AlkermesAmylinAstraZenecaBristol-Myers SquibbBydureonDiabetesPharmaceuticalRegulationUSA

FDA approves Myalept, the first drug to treat a rare metabolic disease

FDA approves Myalept, the first drug to treat a rare metabolic disease

26-02-2014

The US Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy…

AstraZenecaBristol-Myers SquibbmetreleptinMyaleptNorth AmericaPharmaceuticalRare diseasesRegulationUSA

NICE guidance will deprive UK patients with newly-diagnosed advanced melanoma of Yervoy

25-02-2014

US drug major Bristol-Myers Squibb today expressed its disappointment that the UK drugs watchdog the…

Bristol-Myers SquibbNorthern EuropeOncologyPharmaceuticalPricingRegulationUKYervoy

FDA Breakthrough designation for all-oral daclatasvir for chronic hepatitis C

24-02-2014

The US Food and Drug Administration has granted drug major Bristol-Myers Squibb’s investigational DCV…

Anti-viralsBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

22-01-2014

The European Commission has approved Anglo-Swedish drug major AstraZeneca and soon to be ex-partner USA-based…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesPharmaceuticalRegulationXigduo

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

US FDA approves AstraZeneca’s Farxiga to treat type 2 diabetes

09-01-2014

Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday approved Anglo-Swedish…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesFarxigaNorth AmericaPharmaceuticalRegulationUSA

Ono Pharma files for approval of nivolumab for melanoma in Japan

30-12-2013

Japanese drugmaker Ono Pharmaceutical has filed an application to obtain a manufacturing and marketing…

Asia-PacificBristol-Myers SquibbnivolumabOncologyOno PharmaceuticalPharmaceuticalRegulation

Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug

Strong FDA advisory panel backing for Bristol-Myers/AstraZeneca’s diabetes drug

13-12-2013

The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesForxigaNorth AmericaPharmaceuticalRegulation

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