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Ibex Medical Analytics achieves notable milestones with its AI-first approach to cancer diagnostics

Ibex Medical Analytics (Ibex), the leader in artificial intelligence (AI)-powered cancer diagnostics, announced major advancements in customer growth, validation through a Quest Diagnostics study, regulatory approvals and expansion of its Board of...

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...

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...

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...

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...

Genentech to Reintroduce Susvimo for Wet Age-related Macular Degeneration (AMD) Treatment

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the reintroduction of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people in the United States (U.S.) with...

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...

FDA Grants Second Approval for EPKINLY® (epcoritamab-bysp) to Treat Relapsed or Refractory Follicular Lymphoma

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or...

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...

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)...

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...

Regulus Therapeutics Progresses to Cohort 4 in Phase 1b MAD Trial of RGLS8429 for ADPKD Treatment

Regulus Therapeutics Inc. a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs today announced, after review of all available safety data, the Company initiated screening of the fourth...

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...

Hyalex Orthopaedics Reports Treatment of First Patients with Novel HYALEX® Knee Cartilage System

Hyalex Orthopaedics, a privately held medical device company developing cartilage repair products based on the transformative HYALEX® materials platform, announced that patients have successfully received HYALEX Knee Implants as part of the...

ImmunityBio Announces FDA Approval of ANKTIVA®,

ImmunityBio, Inc. an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with...

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...

Kiromic BioPharma reports positive results from third patient in Deltacel-01 trial

Kiromic BioPharma, Inc. reports early efficacy results showing tumor stabilization in the third patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic....

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