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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

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

FDA approves Gilead’s Harvoni, the first combo pill for hepatitis C

12-10-2014

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’…

Anti-viralsBiotechnologyGilead SciencesHarvoniPricingRegulationSovaldiUSA

Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24-09-2014

Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationsofosbuvir

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

UK NICE consults on draft guidance for hepatitis C drug Olysio

UK NICE consults on draft guidance for hepatitis C drug Olysio

18-09-2014

In draft guidance published today UK drugs watchdog the National Institute for Health and Care Excellence…

Anti-viralsJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulationUK

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

Added benefit for certain patients found by IQWiG with Janssen’s Olysio

15-09-2014

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsGermanyJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulation

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

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

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