Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme’s ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP)…
Olverembatinib Included in Newest Guidelines on Chronic Myeloid Leukemia (CML) Management from the National Comprehensive Cancer Network (NCCN)
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that olverembatinib (R&D Code: HQP1351) has been included in the latest guidelines from the National Comprehensive Cancer…
Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from the Company’s recently…
U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular…
Endovascular Engineering’s Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism
Endovascular Engineering (“E2”), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption (IDE) approval for its ENGULF US pivotal trial. This study will…
Calliditas refinances existing term loan with Euro 92 million senior secured facility with Athyrium Capital
Calliditas Therapeutics AB (Nasdaq: CALT) and (Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the company has signed and fully drawn a term loan of 92 million Euros with funds managed by Athyrium Capital Management, LP (“Athyrium”). Proceeds from the loan will primarily be utilized for…
NRx Pharmaceuticals Announces Signing of a Data and Technical Information Agreement with Columbia University Accessing Key Data Demonstrating Efficacy and Safety of Intravenous Ketamine for the Treatment of Suicidal Depression
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that it has signed a License Data and Technical Information Agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for…
WAINUA™ (eplontersen) granted regulatory approval in the U.S. for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca’s WAINUA™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. WAINUA…
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…
