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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

Astellas' isavuconazole NDA accepted by US FDA

Astellas' isavuconazole NDA accepted by US FDA

08-09-2014

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major…

Astellas PharmaFungal diseasesInvasive aspergillosisInvasive mucormycosisisavuconazoleOncologyPharmaceuticalRegulationUSA

UK’s NICE recommends Xtandi and Yervoy under patient access schemes

UK’s NICE recommends Xtandi and Yervoy under patient access schemes

23-07-2014

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

Astellas PharmaBristol-Myers SquibbOncologyPharmaceuticalRegulationUKXtandiYervoy

Astellas submits sNDA for Irribow/Irribow OD in Japan

Astellas submits sNDA for Irribow/Irribow OD in Japan

14-07-2014

Japanese drug major Astellas Pharma has submitted a supplemental New Drug Application for the indication…

Astellas PharmaGastro-intestinalsIrribowJapanPharmaceuticalRegulation

NICE issues positive recommendation for Astellas' Xtandi

NICE issues positive recommendation for Astellas' Xtandi

09-05-2014

In an about turn, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

Astellas PharmaOncologyPharmaceuticalPricingRegulationUKXtandi

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

Astellas gains Japanese clearance for diabetes drug Suglat

Astellas gains Japanese clearance for diabetes drug Suglat

20-01-2014

Japanese drug major Astellas Pharma has obtained the marketing approval of selective SGLT2 inhibitor…

Asia-PacificAstellas PharmaDiabetesipragliflozinKotobuki PharmaceuticalMerck & CoPharmaceuticalRegulationSuglat

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

FDA backs Astellas' Astragraf XL for kidney transplant rejection prophylaxis

22-07-2013

The US Food and Drug Administration has approved Japanese drug major Astellas Pharma's (TYO: 4503) Astragraf…

Astellas PharmaAstragraf XLImmunologicalsNorth AmericaPharmaceuticalRegulationtacrolimus

IQWiG finds added benefit for Dificlir in C. difficile infections

16-07-2013

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information…

Antibiotics and Infectious diseasesAstellas PharmaDificlirEuropePharmaceuticalPricingRegulation

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

Additional indications in Japan for Roche's Avastin and Astellas' Prograf

17-06-2013

Swiss drug major Roche (ROG: SIX) says that the Japanese Ministry of Health, Labor and Welfare (MHLW)…

Asia-PacificAstellas PharmaAvastinBiotechnologyImmunologicalsOncologyPharmaceuticalPrografRegulationRoche

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine

11-06-2013

US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

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