BioSpace News Archive

FDA

Innovent Biologics Announces FDA Approval of Pemazyre™ (Pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

Innovent Biologics, Inc. announced that the U.S. Food and Drug Administration has approved Pemazyre™, a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.

April 19, 2020
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11 min read
Policy

Fosun Pharma Receives FDA Emergency Use Authorization (EUA) For Its COVID-19 RT-PCR Detection Kit

SHANGHAI, April 19, 2020 According to the website of the U.S. Food and Drug Administration, Shanghai Fosun Pharmaceutical Co., Ltd has received emergency use authorization from FDA for its COVID-19 RT-PCR detection kit.

April 19, 2020
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1 min read
Business

Statement by the Prime Minister on National Volunteer Week

The Prime Minister, Justin Trudeau, issued the following statement on National Volunteer Week

April 19, 2020
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1 min read
Drug Development

Ascendis Pharma A/S Announces Top-line Data from Fixed Dose Portion of Phase 2 Trial Demonstrating Potential of TransCon™ PTH as a Replacement Therapy for Hypoparathyroidism

PaTH Forward Trial met key objectives and showed that TransCon PTH eliminated standard of care in 82 percent of subjects within four weeks

April 19, 2020
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10 min read