Current Headlines

  1. Tenpoint Therapeutics Ltd. Announces FDA Acceptance Of New Drug Application For BRIMOCHOL PF For The Treatment Of Presbyopia 6/3/2025

    Tenpoint Therapeutics, Ltd. (“Tenpoint”), a global, clinical-stage biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, today announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for BRIMOCHOL PF for the treatment of presbyopia.

  2. Orbis Medicines Accelerates Next-Generation Oral Macrocycle Platform With Enhanced Artificial Intelligence Capabilities Of Gefion Supercomputer 6/3/2025

    Orbis Medicines, a leader in oral macrocycle drug discovery, and the Danish Center for AI Innovation (DCAI) today announced that Orbis has begun using Denmark’s first AI supercomputer, Gefion, which is owned and operated by DCAI.

  3. Kivu Bioscience Selects Sterling Pharma Solutions For cGMP Manufacturing Of Lead Oncology Antibody-Drug Conjugate KIVU-107 6/2/2025

    Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates, announced today a manufacturing partnership with Sterling Pharma Solutions, a global contract development and manufacturing organisation, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107.

  4. BioNTech And Bristol Myers Squibb Announce Global Strategic Partnership To Co-Develop And Co-Commercialize Next-Generation Bispecific Antibody Candidate BNT327 Broadly For Multiple Solid Tumor Types 6/2/2025

    BioNTech SE and Bristol Myers Squibb today announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.

  5. ImmunAbs Announces FDA Phase 2 IND Approval Of IM-101, A Novel Complement C5 Inhibitor, For Treatment Of Myasthenia Gravis 6/2/2025

    ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating the safety and efficacy of IM-101, a novel complement C5 inhibitor, for the treatment of Myasthenia Gravis.

  6. Bambusa Therapeutics Announces First Subject Dosed In Phase 1 Clinical Trial Of BBT002, A Novel Platform-In-A-Molecule Bispecific Antibody For Broad I&I Conditions And U.S. FDA Clearance Of IND Application For BBT001 5/30/2025

    Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biotechnology company developing novel biologics for inflammatory and immunological diseases, today announced that it has completed the initial dosing in healthy volunteers (HV) in its clinical trial for BBT002, a novel, half-life extended bispecific antibody designed as a "platform in a molecule" with broad applications across respiratory, dermatology, and gastroenterology.

  7. Astellas Enters Exclusive License Agreement With Evopoint Biosciences For XNW27011, A Novel Clinical-Stage Antibody-Drug Conjugate Targeting CLDN18.2 5/29/2025

    Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) today announced they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2.

  8. Charles River And CHDI Foundation Extend Multi-Decade Collaboration On Huntington's Disease Research 5/28/2025

    Charles River Laboratories International, Inc. and CHDI Foundation, Inc., today announced an extension of their ongoing drug discovery partnership into the foreseeable future.

  9. HCVC Leads kyron.bio €5.5M Round To Use Glycan Engineering For Advanced Drug Design 5/28/2025

    One of the biggest challenges facing biologic drug developers are varying efficacy and the dangers of side effects. Biotechnology company kyron.bio today announced a €5.5 million funding round to solve these issues using precise control of sugar molecules found on the surface of a drug - also known as glycans.

  10. Eton Pharmaceuticals Announces U.S. FDA Approval For KHINDIVI™ (Hydrocortisone) Oral Solution 5/28/2025

    Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency.