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Nyxoah Receives IDE Approval from the U.S. Food and Drug Administration (FDA) for its DREAM Study

Nyxoah Receives IDE Approval from the U.S. Food and Drug Administration (FDA) for its DREAM Study

Mont-Saint-Guibert, Belgium, June 25 (Korea Bizwire) - Nyxoah S.A., a healthtech company focused on the development and commercialization of innovative solutions and services to treat sleep disordered breathing conditions, today announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to allow Nyxoah to commence its pivotal DREAM [...]

Philips Receives FDA Premarket Approval for its HeartStart FR3 and HeartStart FRx Automated External Defibrillators

Philips Receives FDA Premarket Approval for its HeartStart FR3 and HeartStart FRx Automated External Defibrillators

Amsterdam, the Netherlands and Cambridge, MA, June 23 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 [1] and HeartStart FRx [2] automated [...]

S. Korean Company to Start Clinical Trial for Potential Coronavirus Treatment in U.S.

S. Korean Company to Start Clinical Trial for Potential Coronavirus Treatment in U.S.

SEOUL, June 11 (Korea Bizwire) — South Korean biopharmaceutical maker Genexine Inc. said Thursday it has won approval to conduct a clinical trial for its potential coronavirus treatment in the United States. The U.S. Food and Drug Administration (FDA) gave the green light for the phase 1 clinical trial of anti-cancer drug candidate GX-I7 for [...]

Helsinn Announces FDA Acceptance of IND Application

Helsinn Announces FDA Acceptance of IND Application

Lugano, Switzerland, June 8 (Korea Bizwire) - Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, today announced that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a “Study May Proceed” letter for [...]

US FDA Grants Mexiletine Orphan Drug Designation

US FDA Grants Mexiletine Orphan Drug Designation

Zug, Switzerland, June 8 (Korea Bizwire) - Lupin is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders. Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia. Myotonia is an inability [...]

FDA Issues Emergency Use Authorization for Philips’ New Acute Care Patient Monitoring Solutions for Hospital-based Remote Monitoring

FDA Issues Emergency Use Authorization for Philips’ New Acute Care Patient Monitoring Solutions for Hospital-based Remote Monitoring

Amsterdam, the Netherlands, June 2 (Korea Bizwire – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the US FDA has issued an Emergency Use Authorization (EUA) for Philips’ IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85, for use in the US during the COVID-19 health emergency [1]. These patient [...]

Philips Receives FDA Clearance for the Use of its Ultrasound Portfolio to Manage COVID-19-related Lung and Cardiac Complications

Philips Receives FDA Clearance for the Use of its Ultrasound Portfolio to Manage COVID-19-related Lung and Cardiac Complications

Amsterdam, the Netherlands, May 13 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and cardiac complications. Handheld and portable [...]

FDA Lifts Injunction on Manufacture and Distribution of Philips’ Defibrillators in the U.S.

FDA Lifts Injunction on Manufacture and Distribution of Philips’ Defibrillators in the U.S.

Amsterdam, the Netherlands, April 24 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced today that its Emergency Care and Resuscitation (ECR) business is resuming manufacturing and shipping of external defibrillators for the US, following notification from the US Food and Drug Administration (FDA) that the injunction prohibiting those activities [...]