Page 34 - Breakthrough Designation News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Share this article Share this article ROCKVILLE, Md., and BEIJING, Dec. 23, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announces that the Chinese Center for Drug Evaluation, a division of the China National Medical Products Association, has granted Breakthrough Therapy Designation ("Breakthrough Designation") to its partner Juventas Cell Therapy Ltd. for CNCT19, a potential CD19 CAR-T therapy for the treatment of adults with relapsed/ref...

(1) PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The RADIANCE-HTN TRIO trial evaluated the efficacy and safe...

Share this article Share this article PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise™ Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The RADIANCE-HTN TRIO...