Formulation Development
Monte Rosa Therapeutics Announces First Subjects Dosed in Phase 1 Study of a NEK7-Directed Molecular Glue Degrader for the Treatment of Multiple Inflammatory Diseases
Monte Rosa Therapeutics, Inc. recently announced the first subjects have been dosed in a Phase 1 study evaluating MRT-8102, a NEK7-directed MGD being developed for…
Tiziana Life Sciences Announces Immunologic Analysis of Nasal Foralumab in Moderate Alzheimer's Patient
Tiziana Life Sciences, Ltd. recently announced compelling immunologic findings from the treatment of a moderate Alzheimer's Disease (AD) patient with intranasal foralumab. Transcriptional analysis of white…
ImCheck’s Announces EMA Orphan Drug Designation for ICT01 as Treatment for Acute Myeloid Leukemia
ImCheck Therapeutics recently announced the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A)…
Longeveron Announces Licensing of New Cardiac Selective Induced Pluripotent Stem Cell Technology for Cardiovascular Disease
Longeveron Inc. recently announced it has licensed an issued US patent (12,168,028 B2) for a stem cell technology from the University of Miami. The composition…
Sanner Celebrates Grand Opening of First US Production Facility in Greensboro, NC
Sanner officially opened its first US-based production facility in Greensboro, NC, just weeks after commencing initial operations. This marks a strategic milestone in the company’s…
UroGen Announces 5-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI in Patients With Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd. recently announced the publication of results of a5-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for…
ArriVent’s Topline Pivotal Phase 3 FURVENT Data for Firmonertinib in First-Line NSCLC EGFR Exon20 Insertion Mutations Projected to be Early 2026
ArriVent BioPharma, Inc. recently announced that topline firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study in first-line EGFR exon20 insertion mutant…
Lexicon Announces Patient-Reported Data on Diabetic Peripheral Neuropathic Pain
Lexicon Pharmaceuticals, Inc. recently announced data from a study of patients describing the impact of diabetic peripheral neuropathic pain (DPNP) despite treatment with standard of…
Lisata Therapeutics & WARPNINE Announce iLSTA Trial Enrollment Completion & Provide Preliminary Data Update
Lisata Therapeutics, Inc. and WARPNINE Incorporated recently announced the successful completion of patient enrollment in the Phase 1b/2a iLSTA trial (ACTRN12623000223639) in Australia. The study…
Gelteq Announces Agreement With IDT Australia to Secure Dedicated New Product Development & Manufacturing Facilities
Gelteq Limited recently announced it has entered into a memorandum of understanding with IDT Australia (ASX: IDT) for a dedicated, locally based manufacturing facility to…
Genascence Announces FDA Grants Regenerative Medicine Advanced Therapy Designation to GNSC-001 for Knee Osteoarthritis
Genascence Corporation recently announced the US FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001, a potential first-in-class gene therapy blocking interleukin…
Quetzal Therapeutics Debuts With Expert Leadership, High-Impact Pipeline & $50 Million of Committed Capital
Quetzal Therapeutics, a newly formed biopharmaceutical company, announced its official launch today with $50 million of committed capital. Founded to address urgent unmet needs in…
Cereno Scientific Announces Positive Topline Results From Phase 1 Trial of a Novel HDAC Inhibitor Supporting Advancement Into Phase 2
Cereno Scientific recently announced positive topline results from its Phase 1 trial of CS014, a novel HDAC inhibitor in development for idiopathic pulmonary fibrosis (IPF).…
Safi Biotherapeutics & Functional Fluidics Initiate Collaboration to Validate Health & Quality of Manufactured RBCs
Safi Biotherapeutics and Functional Fluidics recently announced a collaboration focused on validating the health and quality of Safi’s mRBCs to enable Safi to prepare a…
Amphista Therapeutics Announces Research Milestone in its Collaboration With Merck Triggering Milestone Payment
Amphista Therapeutics recently announced the successful achievement of a discovery research milestone under its exclusive research collaboration and license agreement with Merck. In conjunction with…
Oragenics, Announces US-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development
Oragenics, Inc. rrecently announced it has entered into a manufacturing agreement with Sterling Pharma Solutions, an industry leading CDMO with multiple US-based development and manufacturing…
Biocon Biologics Expands Diabetes Portfolio With FDA Approval of the First & Only Interchangeable Rapid-Acting Insulin Aspart in the US
Biocon Biologics Ltd (BBL) recently announced the US FDA has approved Kirsty (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog…
Acumen Pharmaceuticals & JCR Pharmaceuticals Enter Strategic Collaboration, Option & License Agreement to Develop Enhanced Brain Delivery Therapy for Alzheimer’s Disease
Acumen Pharmaceuticals, Inc. recently announced a collaboration, option, and license agreement with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery (EBD) therapy for Alzheimer’s…
BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer
BriaCell Therapeutics Corp. recently announced the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612)…
AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset Into Phase 1/2 Clinical Trial
AAVantgarde Bio recently announced the US FDA has cleared its Investigational New Drug (IND) application for AAVB-039, the company’s gene therapy program for Stargardt disease.…
