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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

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

28-01-2014

UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance…

Astellas PharmaEuropeOncologyPharmaceuticalPricingRegulationUKXtandi

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

Regulator backs Inlyta, Lucentis and Xtandi for NHS Scotland, but not Bosulif

12-11-2013

The Scottish Medicines Consortium (SMC) revealed this morning (November 12) that it has accepted US drug…

Astellas PharmaBosulifEuropeInlytaLucentisNovartisOncologyOphthalmicsPfizerPharmaceuticalRegulationXtandi

UK’s NICE approves Astellas Pharma’s new prostate cancer drug

UK’s NICE approves Astellas Pharma’s new prostate cancer drug

18-10-2013

NICE has issued new draft guidance recommending Xtandi from Astellas Pharma as an option for treating…

Astellas PharmaEuropeOncologyPharmaceuticalRegulationXtandi

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

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