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Oncologic Drugs Panel to Review Y-mAbs BLA

[ Price : $8.95]

Federal Register notice: FDA announces a 10/28 Oncologic Drugs Advisory Committee meeting.

Panel to Vote on SolvD Genetic Test

[ Price : $8.95]

Federal Register notice: FDA announces a 10/20 advisory committee meeting that will vote on a SolvD test to identify opioid use di...

FDAs Whole-of-Government Approach to Illicit Products

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FDA officials say the agency is taking a whole-of-governments approach to combating the entry of illicit healthcare products into ...

FDA Clears Viz.ai Algorithm

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FDA clears a Viz.ai algorithm to give the ratio between right and left ventricle diameters in a patients heart for use in pulmonar...

Former Pharmatech CEO Gets 37 Months in Jail

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A Florida federal judge sentenced the former CEO of Pharmatech to 37 months in federal prison after he pled guilty to several char...

Ascendis NDA for Hypoparathyroidism Therapy

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Ascendis Pharma files an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to ...

FDA Observations from 3 Biocon Biologics Inspections

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FDA issues a form FDA-483 with multiple inspection observations to Indias Biocon Biologics following three inspections at manufact...

Cue Health Seeks De Novo for At-Home Flu Test

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Cue Health files a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care use.

GDUFA Research Supports Generic Drug Development

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The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the develo...

FDA, C-Path Exploring Lysosomal Diseases Group

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FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Acce...