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AUM Biosciences Receives U.S. FDA Rare Pediatric Disease Designation for AUM302 for Treatment of Neuroblastoma

AUM Biosciences Receives U.S. FDA Rare Pediatric Disease Designation for AUM302 for Treatment of Neuroblastoma

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 [...]

Kineta Announces FDA Acceptance of Investigational New Drug (IND) Application for KVA12123 for the Treatment of Advanced Solid Tumors

Kineta Announces FDA Acceptance of Investigational New Drug (IND) Application for KVA12123 for the Treatment of Advanced Solid Tumors

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 [...]

Innova Medical Group Announces Successful FDA Field Inspection Results and Formal Warning Letter Close-Out

Innova Medical Group Announces Successful FDA Field Inspection Results and Formal Warning Letter Close-Out

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 [...]

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for JS110 (XPO1 inhibitor)

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for JS110 (XPO1 inhibitor)

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., [...]

Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio® in Complete Concentric Collapse Patients

Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio® in Complete Concentric Collapse Patients

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 [...]

FDA Approves Genio® 2.1 for Use in DREAM U.S. IDE Pivotal Study

FDA Approves Genio® 2.1 for Use in DREAM U.S. IDE Pivotal Study

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 [...]

Philips Receives FDA 510(k) Clearance for Latest Breakthrough High-performance MR 7700 System

Philips Receives FDA 510(k) Clearance for Latest Breakthrough High-performance MR 7700 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 [...]

Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA

Junshi Biosciences and Coherus Receive Complete Response Letter from U.S. FDA for Toripalimab BLA

SHANGHAI, China, and REDWOOD CITY, Calif., May 2 (Korea Bizwire) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the U.S. Food and Drug Administration (“FDA”, “the Agency”) has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for toripalimab in combination with gemcitabine and [...]

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

SHANGHAI, China, April 3 (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, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal [...]

Latest Release of Philips Capsule Surveillance Receives FDA Clearance

Latest Release of Philips Capsule Surveillance Receives FDA Clearance

Amsterdam, the Netherlands, March 15 (Korea Bizwire) – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced today at HIMSS22 that the latest Philips Capsule Surveillance solution has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA), paving the way for widespread deployment across healthcare systems in the USA. Capable of utilizing streaming data [...]