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TXT CHD Wants Probe of FDA Actions on Pfizer Vaccine [2900 Words] [ Price : $8.95]
Children’s Health Defense calls for a congressional probe of FDA’s handling of a whistleblower’s complaint about poor research practices at a contractor testing Pfizer’s Covid vaccine.
11/10/2021
 
 
TXT FDA OKs Resumption of Inovio Covid Vaccine Trial [2688 Words] [ Price : $8.95]
FDA authorizes Inovio to proceed with the Phase 3 INNOVATE segment of its investigative DNA Covid vaccine clinical trial.
11/10/2021
 
 
TXT FDA Clinical Hold on Pfizer Hemophilia A Trial [2692 Words] [ Price : $8.95]
FDA places a clinical hold on a Pfizer Phase 3 trial of a gene therapy candidate to treat hemophilia A.
11/10/2021
 
 
TXT Ellume Covid Test Recall is Class 1: FDA [2683 Words] [ Price : $8.95]
FDA says the Ellume recall of certain lots of its Covid-19 home test due to an unacceptable level of false-positive results is Class 1.
11/10/2021
 
 
TXT HeartVista MRI Software Cleared for Siemens Scanner [99 Words] [ Price : $8.95]
FDA clears a HeartVista 510(k) to provide its artificial intelligence-assisted One Click MRI acquisition software on Siemens Healthineers MRI scanners.
11/10/2021
 
 
TXT Aligned Medical Solutions Recalls Convenience Kits [109 Words] [ Price : $8.95]
Aligned Medical Solutions recalls its custom convenience kits due to the potential for the plunger on the Cardinal Health Monoject Flush Prefilled Syringe to malfunction.
11/10/2021
 
 
TXT Meridian Bio EUA for Covid Assay [73 Words] [ Price : $8.95]
FDA grants Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for the qualitative detection of the Covid-19 virus.
11/10/2021
 
 
TXT Kaléo Paying $12.7 Million to End False Claims Case [2728 Words] [ Price : $8.95]
The Justice Department says kaléo is paying $12.7 million to resolve a whistleblower’s allegations that it induced false claims for its Evzio anti-opioid overdose drug.
11/10/2021
 
 
TXT Vektor Medical 510(k) for ECG Mapping Tool [115 Words] [ Price : $8.95]
FDA clears a Vektor Medical 510(k) for vMAP, a computational electrocardiogram mapping system for use to improve outcomes in ablation procedures.
11/10/2021
 
 
TXT Regulatory Review Period Determined for Dojolvi [99 Words] [ Price : $8.95]
Federal Register news: FDA determines for patent extension purposes the regulatory review period for Ultragenyx’s Dojolvi (triheptanoin).
11/09/2021
 
 
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