HONG KONG, Dec. 10, 2025 /PRNewswire/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) announced the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody) […]
Tag: International Medical Approval
Third Indication for Kelun-Biotech’s TROP2 ADC Sac-TMT Approved for Marketing by NMPA in EGFRm NSCLC Following Progression on EGFR-TKI Therapy
CHENGDU, China, Oct. 11, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) was approved for marketing by the National […]
WuXi Biologics Secures FDA PLI Approval for Five Facilities, First for Commercial PFS Line
WuXi Biologics’ pre-filled syringes (PFS) commercial production line passed its first FDA inspection, paving the way for global delivery of high-quality PFS solutions to clients worldwide Reinforces WuXi Biologics’ strong track record of a 100% success […]
miraDry® erhält EU MDR-Zertifizierung und erweitert Indikationen zur Schweiß-, Geruchs- und Haarreduzierung in ganz Europa
NEWPORT BEACH, Kalifornien, 11. Juli 2025 /PRNewswire/ — miraDry®, Inc., ein weltweit führendes Unternehmen in der Behandlung von Achselschweiß und -geruch, gab heute bekannt, dass es nun die CE-Kennzeichnung für das miraDry-System gemäß der Medizinprodukteverordnung der […]
miraDry® Secures EU MDR Certification and Expands Indications for Sweat, Odor, and Hair Reduction Across Europe
NEWPORT BEACH, Calif., July 10, 2025 /PRNewswire/ — miraDry®, Inc., a global leader in underarm sweat and odor treatment, announced today it has now obtained CE marking for the miraDry system, under the European Union’s […]
