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FDA grants approval for Xtandi in metastatic prostate cancer

FDA grants approval for Xtandi in metastatic prostate cancer

01-10-2014

Japanese drug major Astellas Pharma and Medivation has received extended approval for Xtandi (enzalutamide)…

Astellas PharmaDiplomatMedivationOncologyPharmaceuticalRegulationUSAXtandi

US priority review for Astellas and Medivation’s sNDA for prostate cancer

US priority review for Astellas and Medivation’s sNDA for prostate cancer

06-05-2014

Japanese drug major Astellas' US subsidiary and Medivation revealed that the US Food and Drug Administration…

Astellas PharmaBiotechnologyMedivationOncologyRegulationUSAXtandi

Astellas files for wider use of prostate cancer drug Xtandi in Europe

03-04-2014

Japanese drug major Astellas Pharma has submitted a variation to amend the Marketing Authorization Application…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalRegulationXtandi

Astellas’ Xtandi cleared in Japan for prostate cancer treatment

24-03-2014

Japanese drug major Astellas Pharma has obtained the marketing approval in Japan of its oral androgen…

Asia-PacificAstellas PharmaJapanMedivationOncologyPharmaceuticalRegulationXtandi

Astellas and Medivation file sNDA for new Xtandi indication

Astellas and Medivation file sNDA for new Xtandi indication

18-03-2014

Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application…

Astellas PharmaMedivationNorth AmericaOncologyPharmaceuticalRegulationUSAXtandi

IQWiG now finds “major” benefit for Xtandi

24-02-2014

In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products…

Astellas PharmaGermanyMedivationNorthern EuropeOncologyPharmaceuticalPricingRegulationXtandi

IQWiG finds hint of added benefit for Xtandi in prostate cancer

IQWiG finds hint of added benefit for Xtandi in prostate cancer

09-12-2013

In an early benefit assessment under the Act on the German Reform of the Market for Medicinal Products…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalPricingRegulationXtandi

Astellas and Medivation's Xtandi approved in EU for advanced prostate cancer

24-06-2013

Japanese drug major Astellas Pharma (TYO: 4503) European subsidiary today (June 24) received approval…

Astellas PharmaEuropeMedivationOncologyPharmaceuticalRegulationXtandi

Astellas and Medivation file for approval of enzalutamide in Japan

24-05-2013

Japanese drug major Astellas Pharma (TYO: 4503) has submitted an application for marketing approval of…

Asia-PacificAstellas PharmaenzalutamideMedivationOncologyPharmaceuticalRegulationXtandi

FDA backs Medivation and Astellas' prostate cancer drug Xtandi

03-09-2012

USA-based Medivation (Nasdaq: MDVN and Japanese drug major Astellas Pharma (TYO: 4503) say that the US…

Astellas PharmaBiotechnologyenzalutamideMedivationNorth AmericaOncologyPharmaceuticalRegulationXtandi

PDUFA Action Date for Astellas enzalutamide; Urogenix facility to close

07-08-2012

The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date…

Astellas PharmaenzalutamideGenito-urinaryMedivationOncologyPharmaceuticalRegulationResearchUrogenixVaccines

Astellas submits prostate cancer drug for EU approval

28-06-2012

Japanese drug major Astellas Pharma (TYO: 4503) yesterday filed a marketing authorization application…

Astellas PharmaenzalutamideEuropeMedivationOncologyPharmaceuticalRegulation

Expanded Access Program for enzalutamide agreed with US FDA

30-05-2012

The US Food and Drug Administration agreed that Medivation (Nasdaq: MDVN) and Japanese drug major Astellas…

Astellas PharmaBiotechnologyenzalutamideMDV3100MedivationNorth AmericaOncologyPharmaceuticalRegulation

Medivation files NDA for prostate cancer drug enzalutamide

23-05-2012

US drug developer Medivation (Nasdaq: MDVN) says it has submitted a New Drug Application to the US Food…

Astellas PharmaenzalutamideMDV3100MedivationNorth AmericaOncologyPharmaceuticalRegulation

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