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FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

FDA priority review for Gilead’s ledipasvir/sofosbuvir fixed-dose combo for hepatitis C

08-04-2014

US anti-virals major Gilead Sciences says that the US Food and Drug Administration has granted priority…

Anti-viralsBiotechnologyGilead SciencesledipasvirNorth AmericaRegulationsofosbuvirUSA

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

US lawmakers question price of Gilead’s Sovaldi

US lawmakers question price of Gilead’s Sovaldi

24-03-2014

Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPoliticsPricingRegulationSovaldiUSA

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

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

Gilead’s Sovaldi approved in Canada for Genotypes 1, 2, 3 or 4 HCV

Gilead’s Sovaldi approved in Canada for Genotypes 1, 2, 3 or 4 HCV

16-12-2013

US antiviral biotech specialist Gilead Sciences says that Health Canada has issued a Notice of Compliance…

Anti-viralsBiotechnologyCanadaGilead SciencesNorth AmericaRegulationsofosbuvirSovaldi

US FDA backs new indication for Gilead's Complera

US FDA backs new indication for Gilead's Complera

14-12-2013

US biotech firm Gilead Sciences’ share closed up 1.6% at $71.40 on Friday, following the news of an…

Anti-viralsBiotechnologyCompleraEvipleraGilead SciencesNorth AmericaRegulation

US FDA approval for Gilead's hepatitis C drug Sovaldi

US FDA approval for Gilead's hepatitis C drug Sovaldi

08-12-2013

US antiviral biotech specialist Gilead Sciences says that the Food and Drug Administration has approved…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPricingRegulationsofosbuvirSovaldi

J&J’s Invokana approved in Europe and Olysio cleared in USA

J&J’s Invokana approved in Europe and Olysio cleared in USA

25-11-2013

It was a good news day for US health care giant Johnson & Johnson, with two of its Janssen subsidiaries…

Anti-viralsDiabetesEuropeInvokanaJanssenJohnson & JohnsonMedivirNorth AmericaOlysioPharmaceuticalRegulation

ViiV Healthcare’s Tivicay approved in Canada for HIV

04-11-2013

ViiV Healthcare, the HIV/AIDS joint venture set up by UK pharma giant GlaxoSmithKline with US behemoth…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

27-10-2013

Following swiftly on a similar decision for Janssen’s hepatitis C drug simeprevir, the US Food and…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaRegulationsofosbuvir

Unanimous FDA panel backing for Janssen’s simeprevir for hep C

Unanimous FDA panel backing for Janssen’s simeprevir for hep C

25-10-2013

Janssen announced yesterday that the FDA's Antiviral Drugs Advisory Committee unanimously recommended…

Anti-viralsJanssenJohnson & JohnsonMedivirNorth AmericaPharmaceuticalRegulationsimeprevir

FDA grants Merck’s hepatitis C treatment breakthrough designation

FDA grants Merck’s hepatitis C treatment breakthrough designation

23-10-2013

US pharma giant Merck & Co has announced that the US Food and Drug Administration has granted MK-5172/MK-8742…

Anti-viralsMerck & CoNorth AmericaPharmaceuticalRegulation

Gilead’s HIV drug booster Tybost gets EU marketing authorization

Gilead’s HIV drug booster Tybost gets EU marketing authorization

27-09-2013

US biotech major Gilead Sciences has received marketing authorization from the European Commission for…

Anti-viralsBiotechnologyEuropeGilead SciencesNorth AmericaRegulationTybost

FDA approves new ViiV Healthcare HIV drug

13-08-2013

The US Food and Drug Administration yesterday (August 12) approved Tivicay (dolutegravir), a new drug…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

AHF claims victory over FDA in HIV prevention drug case

08-08-2013

The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalRegulationTruvada

US FDA approves shipment of quadrivalent flu vaccine to health care providers

06-08-2013

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Vertex slumps as FDA delays hepatitis C trial

26-07-2013

US drug maker Vertex Pharmaceuticals (Nasdaq: VRTX) saw its shares drop 11% to $78 a share, in after-hours…

Anti-viralsBiotechnologyNorth AmericaPharmaceuticalRegulationResearchVertexVX-135

Idenix Pharma slumps as FDA calls for more data on IDX20963

24-06-2013

USA-based biotech firm Idenix Pharmaceuticals (Nasdaq: IDIX) saw its share price plunge as much as 31.8%…

Anti-viralsBiotechnologyIdenix PharmaceuticalsIDX20963North AmericaRegulation

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine

11-06-2013

US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

Bristol-Myers gets added indication from US FDA for Sustiva; signs second deal with Ambrx

06-05-2013

US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved…

AmbrxAnti-viralsBiotechnologyBristol-Myers SquibbCardio-vascularDiabetesLicensingNorth AmericaPharmaceuticalRegulationSustiva

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