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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...

Mediar Therapeutics launches a second clinical program targeting fibrosis with novel first-in-class antibodies

Mediar Therapeutics, Inc., a clinical stage biotechnology company advancing a portfolio of first-in-class therapies designed to halt fibrosis progression, today announced the first cohort of participants has been dosed in a Phase 1 trial...

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...

Lipella Pharmaceuticals initiates Phase 2a trial for LP-310 in oral lichen planus, enrolling the first patients

Lipella Pharmaceuticals Inc. a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the enrollment of the first patients in its multi-center Phase 2a clinical trial evaluating LP-310 for the...

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...

Prolacta Bioscience Leads in Human Milk Science, Regularly Reviewing Health Claims with FDA

Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products, takes its obligation to the critically ill and premature infants it serves, and to the doctors providing them with care, extremely...

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...

Biotheryx Announces First Patient Dosed in Phase 1 Clinical Trial of BTX-9341

Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory diseases, announced that the first patient has been dosed in its...

Cytonics Begins First-In-Human Phase 1 Clinical Study for CYT-108 in Osteoarthritis Knee Patients

Cytonics Corporation, a private biotechnology company developing biologic therapies for musculoskeletal ailments, announced initiation of enrollment for its Phase 1 clinical study of CYT-108. A recombinant variant of the alpha-2-macroglobulin...

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...

PharmAbcine's Phase 1 Trial of PMC-403 for Neovascular Age-Related Macular Degeneration Advances to Single-Dose (4mg) and Multiple-Dose (3mg)

PharmAbcine, Inc. a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, announced today the decision to advance PMC-403, its candidate treatment for neovascular age-related macular degeneration...

CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis

CalciMedica Inc. a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, announced positive topline...

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...

Rigaku Analytical Devices Partners with Leading Pharmaceutical Supplier

Rigaku Analytical Devices, a pioneer in developing handheld 1064 nm Raman analyzers, is pleased to announce distribution relationship Avantor, a leading provider of mission-critical products and services to the life sciences and advanced...

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...

FDA Accepts sBLA Filing of Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Early Alzheimer's Treatment

BioArctic AB's partner Eisai announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly lecanemab-irmb (U.S. brand name: Leqembi)...

Bruker Launches Transformative neofleX MALDI-TOF System

Bruker Corporation announced the launch of a novel, high-performance MALDI-TOF/TOF system, the neofleX Imaging Profiler for mass spectrometry-based tissue imaging. It enables facile OME-TIFF file output via the new SCiLS Scope software. The...

ONFAB, High Potent Containment Provider, Expands into USA Market

ONFAB, a leading European provider of single-use, flexible containment solutions for the pharmaceutical industry, has officially launched business operations in the United States in conjunction with parent company Savillex. The company's American...

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...