BioSpace News Archive

Business

Varian Announces Second Quarter Fiscal Year 2020 Earnings Release Date

Varian announced its second quarter fiscal year 2020 earnings release date.

April 17, 2020
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1 min read
Deals

Marrone Bio Innovations Provides Corporate UpdateFinal Candidate Identified from CEO Search Efforts

Marrone Bio Innovations Inc. provided a corporate update on recent corporate governance and operational initiatives.

April 17, 2020
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5 min read
Policy

Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19

FDA Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products

April 17, 2020
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5 min read
Policy

FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

The U.S. Food and Drug Administration granted accelerated approval to Pemazyre, the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.

April 17, 2020
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4 min read
Policy

Coronavirus (COVID-19) Update: Daily Roundup - April 17, 2020

The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic

April 17, 2020
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4 min read
FDA

FDA Approves Incyte’s Pemazyre™ (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

Pemazyre received Orphan Drug, Breakthrough Therapy and Priority Review designations based on the significant needs of people living with this devastating cancer

April 17, 2020
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13 min read
Biotech Beach

Vivera Pharmaceuticals Supports Telemedicine and Home Testing for COVID-19

Vivera Pharmaceuticals, Inc. a California based pharmaceutical company, is proud to do its part in delivering effective testing for the detection of the COVID-19 causing CoV-2 virus.

April 17, 2020
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2 min read
FDA

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

Foundation Medicine, Inc. announced that the US FDA approved FoundationOne®CDx as the registrational companion diagnostic for Incyte’s Pemazyre™, a selective fibroblast growth factor receptor inhibitor approved for 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 17, 2020
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5 min read