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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) [...]

Nyxoah Receives FDA Approval for Full-body 1.5T and 3T MRI Compatibility for the Genio® System to Treat Obstructive Sleep Apnea (OSA)

Mont-Saint-Guibert, Belgium, Feb. 9 (Korea Bizwire) – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA), today announces that the Company has received approval by the Food and Drug Administration (FDA) for the Magnetic Resonance Imaging (MRI) conditional [...]

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

SHANGHAI, China, Jan. 25 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. Meanwhile, the FDA has also approved [...]

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

GAITHERSBURG, Md., Nov. 9 (Korea Bizwire) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made [...]

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma

SHANGHAI, China, Sept. 17 (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 recently granted Orphan Drug designation to Toripalimab for the treatment of soft tissue sarcoma. This is [...]

Junshi Biosciences Receives FDA Breakthrough Therapy Designation for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

SHANGHAI, China, Sept. 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 US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma. Toripalimab is [...]

Philips and B. Braun Receive FDA Clearance for Breakthrough Onvision Needle Tip Tracking Technology for Regional Anesthesia

Amsterdam, the Netherlands, Aug. 25 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and B. Braun, a global market leader [1] in regional anesthesia and pain management, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision, a breakthrough ultrasound guidance solution for real-time needle tip [...]

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

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.

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 [...]