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Bristol-Myers’ daclatasvir NDA resubmission accepted by FDA

Bristol-Myers’ daclatasvir NDA resubmission accepted by FDA

13-03-2015

US pharma major Bristol-Myers Squibb says that its resubmitted New Drug Application for daclatasvir (proposed…

Anti-viralsBiotechnologyBristol-Myers SquibbdaclatasvirDaklinzaRegulationsofosbuvirUSA

Pfizer receives European approval for Prevenar 13 expanded indication

Pfizer receives European approval for Prevenar 13 expanded indication

04-03-2015

The European Commission has approved an expanded indication for the world’s most most widely used pneumococcal…

Anti-viralsEuropePfizerPharmaceuticalPrevenarRegulation

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

NICE draft guidance backs Gilead’s Harvoni for treating chronic hepatitis C

03-03-2015

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England,…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationUK

NICE recommends Sovaldi and Olysio for hepatitis C

NICE recommends Sovaldi and Olysio for hepatitis C

25-02-2015

The UK’s National Institute for Health and Care Excellence (NICE) has published final guidance recommending…

Anti-viralsGilead SciencesJanssenOlysioPharmaceuticalRegulationSovaldiUK

IQWiG sees benefits for Triumeq and Eperzan

05-02-2015

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has announced its latest findings…

Anti-viralsDiabetesEperzanGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTriumeqViiV Healthcare

FDA approves Bristol-Myers Squibb's Evotaz in HIV-1

FDA approves Bristol-Myers Squibb's Evotaz in HIV-1

02-02-2015

US drug major Bristol-Myers Squibb has received approval from the US Food and Drug Administration for…

Anti-viralsBristol-Myers SquibbEvotazPharmaceuticalRegulation

Janssen's Prezcobix approved for HIV in the USA

Janssen's Prezcobix approved for HIV in the USA

30-01-2015

The US Food and Drug Administration has approved Prezcobix (darunavir 800mg/cobicistat 150mg) tablets,…

Anti-viralsJanssenPharmaceuticalPrezcobixRegulationUSA

EC approves AbbVie’s Viekirax + Exviera for hepatitis C

EC approves AbbVie’s Viekirax + Exviera for hepatitis C

16-01-2015

The European Commission has granted marketing authorizations for US drugmaker AbbVie’s all-oral, short-course,…

AbbVieAnti-viralsEuropeExvieraPharmaceuticalRegulationViekirax

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

UK NICE recommends hepatitis C drugs Sovaldi and Olysio

16-01-2015

In final draft guidance issued today, England health costs watchdog the National Institute for Health…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioPricingRegulationSovaldiUK

Merck & Co updates on plans to accelerate new drug submissions and future growth

Merck & Co updates on plans to accelerate new drug submissions and future growth

13-01-2015

US pharma giant Merck & Co has reported on the ongoing execution of its multi-year, strategic initiative…

Anti-viralsgrazoprevir/elbasvirKeytrudaMerck & CoOncologyPharmaceuticalRegulationResearchUSA

ViiV’s Triumeq offers added benefit for treatment-naive adults with HIV, says IQWiG

ViiV’s Triumeq offers added benefit for treatment-naive adults with HIV, says IQWiG

08-01-2015

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), which had already assessed a…

Anti-viralsGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTriumeqViiV Healthcare

Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

29-12-2014

Swiss drug major Roche has received Emergency Use Authorization for its LightMix Ebola Zaire rRT-PCR…

Anti-viralsPharmaceuticalRegulationRocheWest Africa

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

FDA approves fourth hepatitis C drug, AbbVie’s Viekira Pak

20-12-2014

The US Food and Drug Administration on Friday confirmed the much anticipated approval of US pharma company…

AbbVieAnti-viralsPharmaceuticalRegulationUSAViekira Pak

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

13-12-2014

French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food…

Anti-viralsFluzonePharmaceuticalRegulationSanofiSanofi PasteurUSAVaccines

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

05-12-2014

The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic…

Abacavir Sulfate and Lamivudine TabletsAnti-viralsGenericsMylanRegulationUSA

Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

Two batches of Novartis' Fluad taken off market for investigation in Italy after 13 deaths

01-12-2014

The Italian Medicines Agency (AIFA) has suspended two batches of Swiss drug major Novartis’ Fluad seasonal…

Anti-viralsFluadItalian Medicines AgencyItalyNovartisPharmaceuticalRegulation

US FDA requests additional data for Bristol-Myers Squibb's daclatasvir

US FDA requests additional data for Bristol-Myers Squibb's daclatasvir

27-11-2014

US pharma major Bristol-Myers Squibb has received a Complete Response Letter from the US Food and Drug…

Anti-viralsBristol-Myers SquibbdaclatasvirPharmaceuticalRegulationUSA

HIV therapy Rezolsta approved by EC

HIV therapy Rezolsta approved by EC

25-11-2014

Belgium-based Janssen-Cilag International NV, a subsidiary of US health care giant Johnson & Johnson,…

Anti-viralsEuropeJanssen-CilagPharmaceuticalPrezistaRegulation

EMA unit backs new hep C drugs Exviera and Viekirax from AbbVie

EMA unit backs new hep C drugs Exviera and Viekirax from AbbVie

21-11-2014

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

AbbVieAnti-viralsEuropeExvieraPharmaceuticalRegulationViekirax

Gilead Sciences’ Harvoni gains EU approval

Gilead Sciences’ Harvoni gains EU approval

19-11-2014

The European Commission yesterday granted marketing authorization for US biotech antiviral specialists…

Anti-viralsBiotechnologyEuropeGilead SciencesHarvoniRegulationSovaldi

FDA revokes tentative approval of Ranbaxy’s generic Nexium and Valcyte

07-11-2014

Indian generics drugmaker Ranbaxy Laboratories revealed in a Bombay Stock Exchange filing that it has…

Anti-viralsAstraZenecaGastro-intestinalsGenericsNexiumPfizerRanbaxy LaboratoriesRegulationSun PharmaceuticalUSAValcyte

Janssen’s Olysio/sofosbuvir combination cleared by FDA

Janssen’s Olysio/sofosbuvir combination cleared by FDA

06-11-2014

The Food and Drug Administration has approved US health care giant Johnson & Johnson's Olysio (simeprevir)…

Anti-viralsBiotechnologyJohnson & JohnsonMedivirOlysioRegulationsofosbuvirUSA

Medivir concludes Swedish agreement on Olysio-based treatment for hepatitis C

Medivir concludes Swedish agreement on Olysio-based treatment for hepatitis C

31-10-2014

Swedish drugmaker Medivir says it has entered into an agreement with Swedish county councils regarding…

Anti-viralsJanssenJohnson & JohnsonMedivirOlysioPharmaceuticalPricingRegulationSweden

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