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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

US FDA approves Gilead’s Zydelig for three types of blood cancers

US FDA approves Gilead’s Zydelig for three types of blood cancers

24-07-2014

The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US…

BiotechnologyGilead SciencesidelalisibOncologyRegulationUSAZydelig

Janssen submits sNDA for Olysio in combination with sofosbuvir

Janssen submits sNDA for Olysio in combination with sofosbuvir

08-05-2014

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson, has submitted…

Anti-viralsBiotechnologyGilead SciencesJanssenJohnson & JohnsonOlysioRegulationSovaldiUSA

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

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

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 files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

Gilead files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

11-02-2014

US biotech major Gilead Sciences has submitted a New Drug Application (NDA) to the US Food and Drug Administration…

Antibiotics and Infectious diseasesBiotechnologyGilead SciencesledipasvirRegulationsofosbuvirUSA

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

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