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Gilead’s Livdelzi (Seladelpar) receives FDA accelerated approval for primary biliary cholangitis

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in...

OmniSYS rebrands as XiFin Pharmacy Solutions, launches Pharmacy Payor Rate Transparency Monitor, and earns the Pharmacy 500 Award

XiFin, Inc., a leading provider of innovative healthcare information technologies and services that deliver artificial intelligence (AI)-enabled operational efficiency, interoperability, and simplicity, announced that it has unified its products...

Aptar’s Nasal Unidose System will deliver neffy® (epinephrine nasal spray), the first FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis

AptarGroup, Inc. a global leader in drug and consumer product dosing, dispensing and protection technologies, announced that its Unidose Liquid System (Unidose) is the delivery system approved with neffy® (epinephrine nasal spray), the first and...

Citius Pharmaceuticals' LYMPHIR™ wins FDA approval for relapsed/refractory cutaneous T-cell lymphoma

Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...

Clarivate introduces the new OFF-X™ platform for preclinical and clinical safety intelligence

Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, announced the launch of the new OFF-X™ platform. The enhanced solution offers a seamless user experience and unique translational insights. It delivers crucial...

Galderma’s Relfydess™ (RelabotulinumtoxinA) receives positive decision for use in Europe

Galderma announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for RelfydessTM (RelabotulinumtoxinA – previously referred to as QM1114). RelfydessTM is indicated for the temporary improvement...

Teva and Sanofi Announce Accelerated Anti-TL1A Phase 2b Program for Inflammatory Bowel Disease

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Sanofi announced an update to the timing for the anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program investigating the human IgG1-λ2 monoclonal...

Transposon announces Phase 2 results for TPN-101 in treating C9orf72-related ALS and frontotemporal dementia

Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, including Alzheimer's disease, announced final results from its Phase...

MAIA Biotechnology Announces New Updates from Phase 2 Trial of Novel Cancer Treatment Agent

MAIA Biotechnology, Inc.a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune...

Leqembi Secures Approval for Alzheimer's Disease Treatment in Hong Kong

BioArctic AB's partner Eisai announced that the Department of Health in Hong Kong has approved Leqembi® (brand name in Hong Kong, generic name: lecanemab) for treatment of Alzheimer's disease (AD). Treatment with Leqembi should be initiated in...

Hyundai Bioscience Develops Multi-Treatment for Mosquito-Borne Viral Infections, Including Dengue Feve

Hyundai Bioscience (CEO Oh Sang-gi), which is preparing for a dengue fever basket clinical trial in Brazil, announced on the 24th that it has successfully developed a 'multi-treatment drug for mosquito-borne viral infections, including dengue...

BioMarin to Present Data Showcasing VOXZOGO® (vosoritide)'s Impact on Bone Health and Quality of Life in Achondroplasia

BioMarin Pharmaceutical Inc. announced the presentation of new data from an investigator-led analysis of the Phase 2 111-205 study, which demonstrate that children with achondroplasia treated with VOXZOGO® experienced increases in bone length...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

enGene to Showcase Pivotal Phase 1/2 LEGEND Study Details of EG-70 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. (Nasdaq: ENGN) or ("enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today...

Axion BioSystems Adds Affordable Maestro Volt™ to its Industry-Leading MEA System Lineup

Axion BioSystems today announced the launch of the new Maestro Volt™, an affordable benchtop microelectrode array (MEA) system designed to meet the demands of academic labs with lower throughput needs and limited budgets. Featuring the same ease...

TIVDAK® Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

Genmab A/S announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer...

Nature Publication Highlights the Benefits of Tropis® Intradermal

PharmaJet®, a company that strives to improve the performance and outcomes of medicines with its innovative delivery systems, announced the Nature publication1 of Gennova Biopharmaceutical’s Phase 2/3 clinical trial conducted to evaluate the...

Renibus Therapeutics to Present RBT-1 at European Association for Cardio-Thoracic Surgery

Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, announced an oral presentation on RBT-1 at the prestigious, RBT-1 (stannic protoporfin...

Beckman Coulter's DxI 9000 Immunoassay Analyzer

Beckman Coulter Diagnostics, a leader in clinical diagnostics, announced ahead of the congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global), that it has extended the menu of DxI 9000 Immunoassay...

Scientific article highlights Namodenoson as promising for advanced liver cancer and MASH

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced that Biomedicines published an article titled “Namodenoson at the Crossroad of...

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