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Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
4/23/2024
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
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Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System for Ambulatory Use and REMI Vigilenz AI For Event Detection
4/23/2024
Epitel, a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearances for two new innovative technologies: REMI™ Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz™ AI For Event Detection.
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Medicure Receives US FDA Fast Track Designation for MC-1 for PNPO Deficiency
4/23/2024
Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF) announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency.
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Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the First Prescription Digital Therapeutic Authorized for the Treatment of Postpartum Depression (PPD)
4/23/2024
Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
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Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors
4/23/2024
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.
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Curium Enrolls First Prostate Cancer Patients in its Phase 3 SOLAR Trials
4/23/2024
Curium, a world leader in nuclear medicine, announced today that it has successfully enrolled and scanned patients in its SOLAR clinical trials.
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Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder
4/23/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD).
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hC Bioscience Announces Lead Program in Hemophilia and Reports Positive Preclinical Data on Novel Protein Editing Approach Using Anticodon Engineered tRNA
4/23/2024
hC Bioscience today announced preclinical data supporting its lead program in severe hemophilia A at the World Federation of Hemophilia 2024 World Congress in Madrid, Spain.
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Thermedical Successfully Completes Feasibility Study for Treating Cardiac Arrhythmias Using Pulsed Field Ablation in Combination with SERF Ablation
4/23/2024
Thermedical®, a developer of advanced thermal-ablation systems to treat ventricular arrhythmias, announced today that it has completed a feasibility study utilizing Pulsed Field Ablation (PFA) therapy in combination with its SERF Ablation System and Durablate® Catheter for treating ventricular tachycardia (VT).
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China Medical System: New Drug Application of Desidustat Tablets Accepted in China
4/23/2024
China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 22 April 2024, the New Drug Application (NDA) of Desidustat Tablets (“Desidustat Tablets” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA).
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OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors
4/23/2024
OncoC4, Inc today announced that the United States Food and Drug Administration (“FDA”) has cleared the investigational new drug (“IND”) application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors.
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Exo® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure
4/23/2024
Exo ® Launches FDA-Cleared AI on Exo Iris™ to Address Heart Failure.
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Neuronoff Announces Safety and Functionality Success in First-in-Human Trial of Injectrode for Minimally Invasive Chronic Pain Relief (LIFE study)
4/23/2024
Neuronoff, Inc. announced a significant milestone in its mission to transform chronic pain management.
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SAIL Fusion Announces FDA Clearance of its BowTie™ Sacroiliac Fusion System
4/23/2024
SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon proven AO principles, today announced that it has received FDA clearance for its novel BowTie Sacroiliac Fusion System.
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Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia
4/23/2024
Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia.
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Response Pharmaceuticals’ Drug Candidate for the Treatment of Antipsychotic-Induced Weight Gain (AIWG) Achieves Primary Endpoint in Phase 1b Clinical Trial
4/23/2024
Response Pharmaceuticals, Inc today announced positive topline results from its Phase 1b clinical trial evaluating the safety and efficacy of RDX-002.
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ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
4/23/2024
ImmunityBio, Inc., an immunotherapy company, announced that the U.S. Food and Drug Administration has approved ANKTIVA plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
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Artelo Biosciences Announces Publication of Peer-Reviewed Article Highlighting FABP7 as a Promising Novel Target in Cancer Therapy
4/23/2024
Artelo Biosciences, Inc. today announced the publication of an article, “The emerging role of fatty acid binding protein 7 (FABP7) in cancers,” in Drug Discovery Today, a peer-reviewed journal.
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Palisade Bio Enters into Strategic Collaboration with Strand Life Sciences to Advance Precision Medicine Approach
4/23/2024
Palisade Bio, Inc. today announced it has entered into a transformative strategic collaboration with Strand Life Sciences, a leading bioinformatics specialist, aimed at advancing precision medicine for ulcerative colitis (UC) therapy.
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Hera Biotech Announces Positive Interim Results From Endometriosis Diagnostic Study
4/23/2024
Hera Biotech is pleased to report the interim results for its proof-of-concept multi-center clinical trial of the MetriDx™ endometriosis diagnostic test.