U.S. Food and Drug Administration

Initiation of New Patients on Evobrutinib Paused in the U.S.; Fully Enrolled Phase III Evobrutinib Studies Continue

By NewsOnFloor 05 May 2023

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Medidata Drives Diversity in Clinical Trials, Passing 30,000 Studies and 9 Million Participants

Known for its ground-breaking technological innovations in clinical trials, Medidata, a Dassault Systèmes company, has exceeded 30,000 clinical trials and 9 million study participants. These milestone

By NewsOnFloor 03 May 2023

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Kapruvia® approved in Switzerland with additional regulatory decisions expected in H2 2022

Kapruvia® (difelikefalin) is the first and only therapy approved through consortium filing for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients Therapy recen

By NewsOnFloor 30 Apr 2023

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Takeda’s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.S. Food and Drug Administration

Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company

By NewsOnFloor 30 Apr 2023

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U.S. FDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares After on

By NewsOnFloor 18 Apr 2023

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