Tag: approval

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Genetron Health Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Test and Approval for Export by Chinese Authority

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BEIJING–(BUSINESS WIRE)–Genetron Holdings Limited (“Genetron Health”), a China-based precision oncology company that covers full-cycle cancer care, announced that its independently developed detection kit for the...
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Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves’ Ophthalmopathy

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CAMBRIDGE, Mass. & ROTTERDAM, The Netherlands & SUZHOU, China–(BUSINESS WIRE)–Harbour BioMed receives IND approval in China to begin seamless Phase 2/3 clinical trial of HBM9161...
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Foundation Medicine Receives FDA Approval for FoundationOne®CDx as the Companion Diagnostic for Pemazyre™ (pemigatinib), the First FDA-Approved Targeted Therapy for Adults with Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®CDx as the registrational companion diagnostic for Incyte’s Pemazyre™...

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