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FDA Clears First Technology to Distinguish Between Bacterial and Viral Infections Using the Body’s Immune Response – The MeMed BV® Test and MeMed Key® Platform

FDA Clears First Technology to Distinguish Between Bacterial and Viral Infections Using the Body’s Immune Response – The MeMed BV® Test and MeMed Key® Platform

HAIFA, Israel, Boston, MA; Sept. 20 (Korea Bizwire) – MeMed, a leader in the emerging field of advanced host-response technologies, today announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the MeMed BV® test on the point-of-need platform MeMed Key® to help healthcare providers distinguish between bacterial and viral infections. [...]

Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse

Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse

Mont-Saint-Guibert (Belgium), Sept. 14 (Korea Bizwire) – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S. Food and Drug Administration (FDA) has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment [...]

Orphalan Announces FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the Treatment of Wilson’s Disease

Orphalan Announces FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the Treatment of Wilson’s Disease

Paris, France, Sept. 2 (Korea Bizwire) – Orphalan SA, a Company that identifies, develops and delivers worldwide therapies for orphan diseases, today announces that the US Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson’s Disease. Wilson’s Disease is a rare [...]

Junshi Biosciences and Coherus Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Junshi Biosciences and Coherus Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

SHANGHAI, China and REDWOOD CITY, Calif., Sept. 1 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today the completion of the rolling submission of the Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for toripalimab in combination [...]

Philips Receives FDA Breakthrough Device Designation for Laser-assisted IVC Filter Removal Device

Philips Receives FDA Breakthrough Device Designation for Laser-assisted IVC Filter Removal Device

Amsterdam, the Netherlands, July 21 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the FDA has granted Breakthrough Device Designation (BDD) for a laser-assisted inferior vena cava (IVC) filter removal device. The proposed device is intended for ablating tissue to remove an IVC filter when previous methods of [...]

Philips SmartCT 3D Image Acquisition, Visualization and Measurement Software for its Azurion Image Guided Therapy System Receives FDA 510(k) Clearance

Philips SmartCT 3D Image Acquisition, Visualization and Measurement Software for its Azurion Image Guided Therapy System Receives FDA 510(k) Clearance

Intuitive, table-side touchscreen control offers interventionalists enhanced diagnostic confidence and streamlined workflows [1] Full control of image acquisition and analysis from within the sterile zone helps to avoid procedure disruption, saving time and allowing interventionalists to stay focused on their patients Amsterdam, the Netherlands, April 6 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global [...]

Nicopure Labs Announces FDA Acceptance of Additional Halo E-liquid and Hardware Premarket Tobacco Applications

Nicopure Labs Announces FDA Acceptance of Additional Halo E-liquid and Hardware Premarket Tobacco Applications

Tampa, FLA, March 16 (Korea Bizwire) — Nicopure Labs announces that the Food and Drug Association (FDA) has Accepted all Halo Products Pre-Market Tobacco Applications for the Substantive Scientific Review phase.   Just over 6 months after submission, Nicopure Labs’ Pre-Market Tobacco Applications for Halo Turkish Tobacco E-liquid, Halo Triton II Starter Kit, Halo ZERO Starter [...]

Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma

Junshi Biosciences and Coherus BioSciences Announce Initiation of Rolling Submission of BLA for Toripalimab to the U.S. FDA for the Treatment of Nasopharyngeal Carcinoma

SHANGHAI, China and REDWOOD CITY, Calif., March 3 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today the initiation of the rolling submission of the Biologics License Application (“BLA”) for toripalimab to the U.S. Food and Drug Administration (“FDA”) for the [...]

Novartis Entresto® Granted Expanded Indication in Chronic Heart Failure by FDA

Novartis Entresto® Granted Expanded Indication in Chronic Heart Failure by FDA

Basel, Feb. 16 (Korea Bizwire) — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) [...]

Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19

Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19

SHANGHAI, China, Feb. 10 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for investigational etesevimab (JS016 or LY-CoV016) 1400 mg and bamlanivimab (LY-CoV555) [...]