AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
Albumedix Ltd ('Albumedix'), now part of the life science group Sartorius, announces that Recombumin® is critical to the manufacture of the first FDA- licensed chikungunya vaccine.
LONDON, Nov. 16, 2023 /PRNewswire/ -- The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Kanna Health's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to start participant enrollment in a Phase 1 first-in-human clinical trial investigating the Safety and Pharmacokinetics of KH-001 Besylate (KH-001) in Healthy Male Subjects.
Per le persone di età pari o superiore a 18 anni che corrono un rischio maggiore d’esposizione
Evkeeza è un farmaco, primo nel suo genere, approvato dalla Commissione Europea (CE), dalla Food and Drug Administration (FDA) e da Health Canada per il trattamento di una forma ultra rara ed ereditaria di colesterolo alto
SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks BioRay's first project to receive FDA IND approval.
ATLANTA, Oct. 4, 2023 /PRNewswire/ -- The U. S. Food and Drug Administration (FDA) has awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for the treatment of knee osteoarthritis (OA). The second IDE Study will be conducted for the safety and efficacy for the treatment of knee OA compared to saline and will include 15-20 well-respected academic and private practice orthopaedic institutions.
Two implants were successfully conducted as part of the FDA approved Early Feasibility Study in the United States
THE WOODLANDS, Texas and REGENSBURG, Germany, July 25, 2023 /PRNewswire/ -- The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test.
SAN DIEGO, July 21, 2023 /PRNewswire/ -- Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).
