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Mashup Score: 0BioMarin Receives Approval for First Gene Therapy for Adults With Severe Hemophilia A - 10 month(s) ago
Approximately 2500 individuals in the United States could be eligible to receive valoctocogene roxaparvovec.
Source: AJMCCategories: General Medicine Journals and Societies, Latest HeadlinesTweet
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Mashup Score: 0
The FDA accepted a biologics license application resubmission for valoctocogene roxaparvovec as treatment for adults with severe hemophilia A, according to a press release from the agent’s manufacturer.The resubmitted BLA for valoctocogene roxaparvovec (BioMarin), an investigational adeno-associated virus (AAV) vector gene therapy, includes the company’s responses to all deficiencies
Source: www.healio.comCategories: Hem/Onc News and Journals, Latest HeadlinesTweet-
.@US_FDA accepts BLA resubmission for #ValoctocogeneRoxaparvovec for severe hemophilia A. https://t.co/dcyYDXxQ1Q #severehemophilia #hemophilia #BioMarin #HemOnc #OncAlert #Hematology
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Mashup Score: 1
Hear how developers have approached various aspects of the extensive manufacturing process to ultimately bring new and innovative treatments into the hand of patients and where we as an industry still need to focus.
Source: marketing.statnews.comCategories: General Medicine News, Latest HeadlinesTweet-
The drug development process is not for the faint of heart. Hear how developers from #BioNTech and #BioMarin have taken unique approaches to help bring new and innovative treatments to market at our next virtual event. https://t.co/nzCVItheyI https://t.co/UwhfOQe86z
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Mashup Score: 0FDA Issues CRL for Hemophilia A Gene Therapy - 4 year(s) ago
Valoctocogene roxaparvovec would be the first ever approved gene therapy to treat patients with hemophilia A.
Source: HCPLiveCategories: General Medicine News, Latest HeadlinesTweet-
The #FDA recommends that #BioMarin complete Phase 3 clinical trials for #hemophiliaA gene therapy before deciding on approval. https://t.co/lorAshFA7k
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The #FDA has approved #BioMarin’s gene therapy, valoctocogene roxaparvovec, to treat certain adults with severe #hemophiliaA, as determined by FDA-approved testing. Read more! https://t.co/A8rVphlQXc https://t.co/0O6irNibUs