Business Wire

  1. Rubedo Life Sciences Announces U.S. FDA Clearance Of IND For Selective GPX4 Modulating Lead Drug Candidate RLS-1496 For Actinic Keratosis, Expands Clinical Advisory Board 9/17/2025

    Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on discovering and rapidly developing selective cellular rejuvenation medicines targeting aging cells, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1b/2a study with lead drug candidate RLS-1496 in patients with actinic keratosis.

  2. FDA Files Corcept's New Drug Application For Relacorilant As A Treatment For Patients With Platinum-Resistant Ovarian Cancer 9/10/2025

    Corcept Therapeutics Incorporated, a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer

  3. insitro Partners With Lilly To Build First-In-Kind Machine Learning Models To Advance Small Molecule Drug Discovery 9/9/2025

    insitro, a pioneer in machine learning for drug discovery and development, today announced a new collaboration with Eli Lilly and Company (Lilly) to develop advanced machine learning models that can accurately predict key pharmacological properties of small molecules, including their behavior in vivo.

  4. Avenzo Therapeutics Announces FDA Clearance Of Investigational New Drug Application For AVZO-103, A Potential Best-In-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate 9/2/2025

    Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-103 (formerly VAC-103), a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (ADC).

  5. Enlaza Therapeutics Announces Strategic Collaboration With Vertex Pharmaceuticals To Develop War-Lock Drug Conjugates And T-Cell Engagers For Improved Conditioning And Certain Autoimmune Diseases 9/2/2025

    Enlaza Therapeutics (“Enlaza” or the “Company”), the first covalent biologics platform company, today announced a multi-target drug discovery collaboration with Vertex Pharmaceuticals (“Vertex”) to utilize Enlaza’s proprietary War-Lock technology platform to develop small format drug conjugates and T-cell engagers for certain autoimmune diseases and improved conditioning in sickle cell disease and beta thalassemia.

  6. iXCells Biotechnologies Selected To Perform The First Pilot In Patient-Led ALS Precision Medicine Effort 8/26/2025

    Mosaic Neuroscience and iXCells Biotechnologies USA, Inc. (“iXCells”) today announced a groundbreaking pilot project aimed at making it easier to develop precision drugs for ALS, a notoriously complex and deadly disease.

  7. Tivic Receives Two Investigational New Drug Applications For Entolimod For The Treatment Of Acute Radiation Syndrome (ARS) And Advanced Cancers 8/20/2025

    Tivic Health Systems, Inc., a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead candidate, Entolimod.

  8. N-Power Medicine Launches Industry's First Prospective External Control Arm Platform To Dramatically Accelerate Oncology Drug Development And Reduce Reliance On Randomization 8/19/2025

    N-Power Medicine, a company reimagining oncology drug development, today announced the launch of the industry’s first Prospective External Control Arm (ProECA) platform for pharmaceutical and biotechnology partners.

  9. VASTHERA Receives U.S. FDA Clearance To Initiate Phase 1 Clinical Trial Of Pulmonary Arterial Hypertension Drug Candidate, VTB-10 8/19/2025

    On August 6, 2025, VASTHERA Co., Ltd. announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension (PAH), a rare, life-threatening disease marked by elevated blood pressure in the lung arteries.

  10. Altasciences And VoxCell BioInnovation Announce Strategic Collaboration To Advance Preclinical Drug Development 7/31/2025

    Altasciences, a fully integrated drug development solution company, and VoxCell BioInnovation (“VoxCell”), a leader in 3D bioprinting and human-like tissue modeling, are pleased to announce a strategic collaboration aimed at enhancing preclinical research and accelerating the path from discovery to clinical trials.