SEOUL, Oct. 23 (Korea Bizwire) — South Korea’s major pharmaceutical firm Celltrion Inc. said Monday its new autoimmune disease treatment has won approval from the U.S. Food and Drug Administration (FDA). The FDA approved Celltrion’s Zymfentra, a subcutaneous injection formulation of its infliximab Remsima, for maintenance therapy in adults with moderately to severely active ulcerative [...]
SEOUL, Aug. 21 (Korea Bizwire) — South Korean digital health care startup HoneyNaps Co. said Monday its artificial intelligence-based sleep sensing software, Somnum, has won approval for sale from U.S. drug authorities. The U.S. Food and Drug Administration (FDA) granted Section 510(k) clearance, or premarket notification, to Somnum, demonstrating that the medical device is safe [...]
SEOUL, May 4 (Korea Bizwire) — CJ Cheiljedang Corp., a major South Korean food manufacturer, said Thursday its biocompatible polyester material has received approval from the U.S. Food and Drug Administration (FDA) for use as food packaging material. CJ Cheiljedang said the FDA’s approval of amorphous polyhydroxyalkanoate (PHA) — a softer and more rubbery version [...]
SINGAPORE and BETHESDA, Md., Jan. 5 (Korea Bizwire) — AUM Biosciences Pte. Ltd. (“AUM”), a global clinical-stage biotech company focused on discovering and developing precision oncology therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (RPDD) for its product candidate, AUM302, a potential first-in-class oral kinase [...]
SEATTLE, Nov. 15 (Korea Bizwire) — Kineta, Inc. (“Kineta” or the “Company”), a clinical-stage biotechnology company focused on developing next-generation immunotherapies that address cancer immune resistance, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug application (IND) to evaluate its VISTA blocking immunotherapy, KVA12123 (formerly referred to as [...]
PASADENA, Calif., Oct. 24 (Korea Bizwire) — Innova Medical Group, Inc. (“Innova”), a global leader in antigen testing, announced that it has received from the United States Food and Drug Administration (“FDA”) a letter formally closing out the Warning Letter originally sent to the company on June 10, 2021. This close-out letter was received [...]
SHANGHAI, China, Aug. 25 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“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 Suzhou Junjing Biomedical Technology Co., Ltd., a company jointly invested by Junshi Biosciences and Wigen Biomedicine Technology (Shanghai) Co., [...]
Mont-Saint-Guibert, Belgium, July 11 (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 approved an Investigational Device Exemption (IDE) to enable Nyxoah to [...]
Mont-Saint-Guibert, Belgium, June 1 (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 approved the use of Nyxoah’s next generation Genio® 2.1 system [...]
MR 7700 imaging system features an enhanced gradient system for unmatched performance and precision, delivering Philips’ highest image quality to help improve diagnostic outcomes Newest MR innovation from Philips integrates artificial intelligence [1] for improved workflow to enhance patient and staff experience Philips is the first to bring multi nuclei to clinical practice with seamless integration [...]