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FDA Approval

Asep Medical Holdings Inc. is Granted Patent Approval for its AI-based Sepsis Diagnostic Technology in the US

Asep Medical Holdings Inc. (“Asep Inc.” or the “Company“) (CSE: ASEP) (OTCQB: SEPSF) (FSE: JJ8) is pleased to announce that the Company’s AI-based sepsis diagnostic technology, called SepsetER TM, has received successful patent approval in the United States. The Company received confirmation from its attorneys of its US…

Oxford Nanopore and Day Zero Diagnostics Partner to Develop a New Class of Bloodstream Infection Diagnostics

Oxford Nanopore, the company delivering a new generation of nanopore-based molecular sensing technology, and Day Zero Diagnostics (DZD), an infectious disease diagnostics company harnessing the power of whole-genome sequencing and AI to combat the rise of antibiotic-resistant infections, today announced a collaboration…

Tarsier Pharma Announces Successful Type C Meeting with FDA for TRS01 in Noninfectious Uveitis

Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced the successful outcome of a Type C meeting with the U.S. Food and Drug Administration…

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. The chikungunya virus is primarily transmitted to…

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension. The Paradise…

NRx Pharmaceuticals and Nephron Pharmaceuticals Announce Joint Agreement to Develop Intravenous Ketamine to Treat Suicidal Depression

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, (NRx), a clinical-stage biopharmaceutical company and Nephron Pharmaceuticals, Inc. (Nephron), a leading manufacturer of sterile injectable drugs today announced the signing of a development and manufacturing agreement to manufacture a presentation of ketamine suitable…

Sanyou Bio Congratulates KangaBio on their IND Approval for Next-Generation IL-12 Prodrug Cancer Immunotherapy

On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101. KGX101 is a recombinant IL-12 Fc fusion protein designed for intravenous injection. The KGX101 clinical trials will…

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

EBR Systems, Inc. (ASX:EBR), the medical device company developing wireless cardiac pacing systems, is proud to announce that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States have been published in The Journal of American College of Cardiology (JACC). The positive results published in JACC are based on a 1-year follow-up…

Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil

Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). PVST is a condition characterized by an abnormality in the…

Avidity Biosciences Announces New Positive AOC 1001 Data Demonstrating Improvement in Multiple Additional Functional Endpoints and Favorable Long-term Safety and Tolerability in People with Myotonic Dystrophy Type 1

Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced new positive AOC 1001 data demonstrating improvement in multiple additional functional endpoints and favorable long-term safety and…