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Battelle EUA Revoked for Decontamination System

[ Price : $8.95]

Federal Register notice: FDA revokes Battelle Memorial Institutes emergency use authorization for the Battelle Critical Care Decon...

BioFire EUA Revoked After De Novo Granted

[ Price : $8.95]

Federal Register notice: FDA revokes a BioFire Diagnostics emergency use authorization for its BioFire Respiratory Panel 2.1 after...

Amgen Wins Approval for Lung Cancer Therapy

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FDA approves Amgens Lumakras (sotorasib) for treating adult patients with non-small cell lung cancer whose tumors have the KRAS G1...

Appeals Court Rules Against Homeopathic Drug Marketer

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The DC Circuit Court of Appeals affirms a lower court decision recognizing FDAs authority to place homeopathic drugs on its import...

FDA Budget Request Seeks $477 mil. Funding Boost

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FDAs fiscal year 2022 budget request seeks an 8% ($477 million) boost for agency activities.

FDA Reinstates Unapproved Drugs Initiative

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Federal Register notice: FDA withdraws a notice by the previous administration that would have ended the agencys unapproved drugs ...

Guide on Device Post-approval Studies

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Federal Register notice: FDA makes available a draft guidance entitled Procedures for Handling Post-Approval Studies Imposed by Pr...

Device Postmarket Surveillance Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Postmarket Surveillance Under Section 522 of the Federal Fo...

Foresee Pharma NDA Approved for Prostate Cancer

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FDA approves a Foresee Pharmaceuticals NDA for Camcevi (leuprolide mesylate) 42 mg for treating advanced prostate cancer.

FTC Wants AbbVie AndroGel Appeal Denied

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The Federal Trade Commission asks the Supreme Court not to hear AbbVies appeal of lower court decisions holding that it engaged in...