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Biosyngen's BRG01 gets FDA approval for Phase II clinical trial.

Biosyngen is proud to announce that the U.S. Food and Drug Administration (FDA) has approved its BRG01, an EBV-specific CAR-T cell therapy, to proceed with a pivotal Phase lI clinical trial. This marks the first cell therapy to enter Phase lI...

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...

Axion BioSystems extends its agreement with Corning®, granting exclusive rights to distribute its award-winning cell counting device.

Axion BioSystems announced an agreement with Corning Incorporated that continues Corning’s exclusive worldwide distribution rights for the Corning® Cell Counter. The simple yet powerful device, developed by Axion BioSystems and distributed by...

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...

Jade Biosciences launches with $80 million to develop transformative autoimmune disease therapies

Jade Biosciences, Inc. a biotechnology company dedicated to developing best-in-class therapies for patients living with autoimmune diseases, announced the closing of an $80 million financing. The financing was led by Fairmount and Venrock...

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...

NewAmsterdam Pharma announces positive topline data from the Phase 3 BROOKLYN trial of Obicetrapib in heterozygous familial hypercholesterolemia patients

NewAmsterdam Pharma Company N.V a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”). For whom...

AIM ImmunoTech announces the release of the next CEO Corner segment

AIM ImmunoTech Inc. announced the next CEO Corner segment has been published on the Company’s website. In the CEO Corner segment, AIM Chief Executive Officer Thomas Equels provides an overview of the positive data from the Phase 1 clinical trial...

BerGenBio selects 2nd dose in Phase 2a STK11m Non-Small Cell Lung Cancer trial.

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that the independent Data and Safety Monitoring Board (DSMB) for BerGenBio's Phase...

Astellas gets positive CHMP opinion for PADCEV™ and KEYTRUDA® combo in advanced bladder cancer.

Astellas Pharma Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEV™ (enfortumab vedotin, an antibody-drug conjugate...

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...

T3D Therapeutics to present Phase 2 results of T3D-959 for reducing Alzheimer's amyloid plaques

T3D Therapeutics, Inc., a clinical stage drug development company engaged in the development of a new orally administered treatment for Alzheimer's disease (AD), announced that CEO, John Didsbury, will be presenting new Phase 2 results in a...

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...

Mercury Bio's new project includes Los Alamos and the National Center for Genome Resources.

Mercury Bio a New Mexico-based biotech company focused on the development of a novel new drug-delivery platform, has significantly accelerated its research timeline via a strategic collaboration with four major scientific partners throughout the...

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...

Cytoki Pharma Announces Positive Phase 1 Data Showing Potential of CK-0045 to Improve Cardiometabolic Risk Factors

Cytoki Pharma, ApS (Cytoki), a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for metabolic disease, announced positive data from a Phase 1 study evaluating the...

ViroCell Biologics Signs Master Services Agreement With Prominent NCI-Designated Cancer Center

ViroCell Biologics a cell and gene therapy (“CGT”) contract development and manufacturing organization (“CDMO”) specializing in GMP viral vector manufacturing for clinical trials, announces the signing of a five-year Master Services Agreement...

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...

AusperBio's AHB-137 Receives Breakthrough Therapy Designation for Chronic Hepatitis B Treatment

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies for achieving functional cure in chronic hepatitis B (CHB) infection, announced that their...