Regulation - North America, Astellas Pharma


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FDA backs Astellas' Astragraf XL for kidney transplant rejection prophylaxis


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

Astellas PharmaAstragraf XLImmunologicalsNorth AmericaPharmaceuticalRegulationtacrolimus

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


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

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

Fast FDA approval for Bayer's new drug for advanced prostate cancer, Xofigo


The US Food and Drug Administration yesterday (May 15) approved Xofigo (radium Ra 223 dichloride, initially…

AlgetaAstellas PharmaBayerNorth AmericaOncologyPharmaceuticalRegulationXofigo

FDA advisory votes against AVEO and Astellas' cancer drug tivozanib


US biotech firm AVEO Oncology (Nasdaq: AVEO) saw its shares plunge as much as 57% in late trading yesterday…

Astellas PharmaAVEO OncologyBiotechnologyNorth AmericaOncologyPharmaceuticalRegulationtivozanib

Regulatory briefs from Astellas, Janssen, Biogen and Elan, and QRxPharma


The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) says the US Food and Drug Administration…

Anti-viralsAstellas PharmaBiogen IdecBiotechnologyElanEuropeJanssenJohnson & JohnsonMoxDuoNeurologicalNorth AmericaOncologyPharmaceuticalPrezistaQRxPharmaRegulationTarcevaTysabri

Regulatory briefs from Ipsen/Inspiration, Janssen and Astellas


French drugmaker Ipsen (Euronext: IPN) and partner USA-based privately-held Inspiration Biopharmaceuticals…

Astellas PharmaBiotechnologyEuropeInspiration BiopharmaceuticalsIpsenJanssen-CilagJohnson & JohnsonNorth AmericaOBI-1OncologyPharmaceuticalRegulationTarcevaZytiga

AVEO and Astellas file NDA for tivozanib in kidney cancer


USA-based AVEO Oncology (Nasdaq: AVEO) and Japanese drug major Astellas Pharma (TSE:4503) have submitted…

Astellas PharmaAVEO OncologyBiotechnologyNephrology and HepatologyNorth AmericaOncologyPharmaceuticalRegulationtivozanib

FDA backs Medivation and Astellas' prostate cancer drug Xtandi


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

Astellas PharmaBiotechnologyenzalutamideMedivationNorth AmericaOncologyPharmaceuticalRegulationXtandi

FDA approves Astellas' Myrbetriq for overactive bladder


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

Astellas PharmaGenito-urinarymirabegronMyrbetriqNorth AmericaPharmaceuticalRegulation

Expanded Access Program for enzalutamide agreed with US FDA


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


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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