FDA Approval Articles

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01/19/2018 03:37 PM

FDA Extends Approval for Qiagen NSCLC Test as CDx to Boehringer Ingelheim's Gilotrif
Genetic Engineering & Biotechnology News
The FDA has granted Qiagen a Premarket Approval (PMA) supplement extending the authorization of Qiagen's therascreen® EGFR RGQ PCR Kit as a companion diagnostic for Boehringer Ingelheim's targeted cancer treatment Gilotrif® (afatinib). The new ...

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01/19/2018 02:52 PM


AI That Can Predict Death Has Been Given FDA Approval
Using the power of artificial intelligence (AI) doctors could predict when their patients might be knocking on death's door. This isn't merely some grim dystopian prop, the researchers hope it could be used to slash the surprisingly high number of ...

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01/19/2018 01:32 PM

Merck Animal Health receives FDA approval for expanded use of Safe-Guard® AquaSol in poultry
Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced that Safe-Guard® AquaSol (fenbendazole oral suspension), the company's highly effective dewormer, is now approved for use in laying hens and ...

01/19/2018 09:26 AM

Qiagen (QGEN) Announces FDA Approval to Expand Use of EGFR Test in Lung Cancer
QIAGEN N.V. (NYSE: QGEN) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN's therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer ...

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01/18/2018 09:11 PM

Guest column: New tobacco product IQOS deserves FDA approval
Bend Bulletin
To eventually end cigarette use in America, rather than rely on tobacco taxes, public service announcements and restrictions on cigarette use, we might look toward innovation. New technologies hold out the promise of ending deadly cigarette use ...

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01/18/2018 05:39 AM