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BioWorld - Thursday, June 26, 2025
Home » Topics » Regulatory

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ABM-respiratory-biwaze-cough-system.png

FDA nod for ABM Respiratory Care’s Biwaze Cough system

April 1, 2020
By Meg Bryant
Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.
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Regulatory front for April 1, 2020

April 1, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Hydroxychloroquine prescription bottle

Desperation drives shortage of antimalarial drugs used to treat COVID-19

April 1, 2020
By Mari Serebrov
The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.
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FDA accepts Mesoblast’s BLA for pediatric GVHD stem cell therapy under priority review

April 1, 2020
By Tamra Sami
PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
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Regulatory front for April 1, 2020

April 1, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Architectural pillars

Regulatory front for March 31, 2020

March 31, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Association for Accessible Medicines, Department of Justice, EMA, FDA, Federal Trade Commission, International Coalition of Medicines Regulatory Authorities, SEC, White House, World Health Organization.
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3-31-Siemens-RAPIDPoint-500e.png

FDA gives nod to Siemens Healthineers’ Rapidpoint 500e blood gas analyzer

March 31, 2020
By Meg Bryant
Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.
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Regulatory front for March 31, 2020

March 31, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Biotechnology Innovation Organization, Cme America, Ortho-Clinical Diagnostics.
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Amarin stock plummets on district court’s patent ruling on Vascepa

March 31, 2020
By Lee Landenberger
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
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Regulatory front for March 31, 2020

March 31, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Pfizer Healthcare India.
Read More
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