Formulation Development
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.…
Lisata Therapeutics Expands Intellectual Property Portfolio With New Composition of Matter Patent for Certepetide
Lisata Therapeutics, Inc. recently announced the United States Patent and Trademark Office (USPTO) issued the company a new composition of matter patent for certepetide through…
PolyPid Unveils a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Diabetes & Weight Loss Market
PolyPid Ltd. recently unveiled its long-acting GLP-1 receptor agonists (glucagon-like peptide-1 RA) delivery platform that aims to subcutaneously release GLP-1 RA for approximately 60 days,…
Clearmind Expands Clinical Trial for Alcohol Use; New Site Activated & Additional Participant Enrolled
Clearmind Medicine Inc. recently announced the expansion of its Phase 1/2a clinical trial for CMND-100, its proprietary MEAI-based oral treatment candidate for Alcohol Use Disorder…
BiomX Announces Successful Initiation of Phase 2b Trial With First Patient Dosed in BX004 Program in Patients With Cystic Fibrosis
BiomX Inc. recently announced the successful initiation of patient dosing in the company’s Phase 2b trial with first patient dosed. The trial is evaluating BX004…
PCI Pharma Services Enters Next Phase of Growth With Strategic Investment From Bain Capital, Kohlberg & Mubadala
PCI Pharma Services recently announced it received a strategic investment co-led by Bain Capital and existing lead investor Kohlberg, and supported with significant reinvestment by…
Vivos Inc. Submitted the Investigational Device Exemption Application for Human Clinical Trials at Mayo Clinic
Vivos Inc., a pioneer in Precision Radionuclide Therapy (PRnT) solutions, recently announced the submission of its Investigational Device Exemption (IDE) application to the US FDA…
