TG ImmunoPharma Announces FDA Clearance for Clinical Trial of TGI-6 Bispecific Antibody

HEFEI, China, June 16, 2023 /PRNewswire/ — TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of TGI-6, its groundbreaking bispecific antibody. TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling … Read more

The U.S. FDA Approved the Phase I/II Clinical Trial Application to Evaluate LBL-033, An Anti-MUC16/CD3 Bispecific Antibody Developed by Leads Biolabs, in Advanced Solid Tumors Including Ovarian Cancer

NANJING, China, June 16, 2023 /PRNewswire/ — Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as “Leads Biolabs” or “Company”) today announces that the phase I/II clinical trial application for LBL-033, an anti-MUC16/CD3 bispecific antibody, for the treatment of ovarian cancer and other malignant tumors, has been approved by the FDA (U.S. Food and Drug Administration). At … Read more

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

Class II clearance expands the patient population that can be managed  Companies working with Huma’s platform can now launch algorithm innovations more quickly in a compliant and de-risked manner, democratising digital health innovation across the industry Clearance was granted through the FDA’s joint eSTAR programme which aims to increase the efficiency of regulation through digitalisation NEW YORK … Read more

Se otorga la cuarta aprobación IDE de Concept Medical para el balón recubierto de sirolimus MagicTouch para el tratamiento de la enfermedad de la arteria femoral superficial (SFA) USA – español USA – English USA – English USA – Deutsch

TAMPA, Fla., 30 de mayo de 2023 /PRNewswire/ — El 24 de mayo de 2023, la FDA de EE.UU. otorgó una exención de dispositivo de investigación (IDE) para el balón recubierto de sirolimus (SCB) MagicTouch PTA de Concept Medical Inc para el tratamiento de las arterias femorales superficiales (SFA). Esto marca la cuarta aprobación de IDE para el balón … Read more

Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease (SFA)

TAMPA, Fla., May 29, 2023 /PRNewswire/ — The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s Sirolimus Coated Balloon (SCB) MagicTouch  PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the Company’s Sirolimus coated balloon. The Company has … Read more

Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

SHANGHAI, May 26, 2023 /PRNewswire/ — Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.  Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. Pulse Medical has been pioneering and … Read more

Camurus announces FDA approval of Brixadi™ for the treatment of moderate to severe opioid use disorder

Brixadi is the first treatment for opioid use disorder in the US with both weekly and monthly dosing Three million people in the US diagnosed with opioid use disorder LUND, Sweden, May 24, 2023 /PRNewswire/ — Camurus (NASDAQ STO: CAMX) today announces that the US Food and Drug Administration (FDA) has approved Brixadi™ (buprenorphine) extended release … Read more

FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

Agency Continues to Support Innovation of Next-Generation Technology in Diabetes Management SILVER SPRING, Md., May 19, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with … Read more

FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic Epidermolysis Bullosa

SILVER SPRING, Md., May 19, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. … Read more

EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including … Read more