Latest Headlines

  1. SGS Acquires Keystone Bioanalytical, Strengthening End-To-End Drug Development Lifecycle Testing Capabilities For North American Pharma And Biotech Industries 5/4/2026

    SGS, the world's leading testing, inspection and certification company, is pleased to announce that it has acquired Keystone Bioanalytical, a specialized provider of bioanalytical testing services based in Philadelphia, Pennsylvania (United States).

  2. Cellenkos Announces FDA Clearance Of Investigational New Drug (IND) Application For Phase 1b/ 2a Trial Of CK0802 In Steroid-Refractory Graft-versus-Host Disease (GVHD) 5/4/2026

    Cellenkos®, Inc., a clinical stage biotechnology company, pioneering allogeneic, tissue-targeted regulatory T cell (Treg) therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD).

  3. HanchorBio And NYCU Launch AI-Enabled Drug Discovery Collaboration To Advance Next-Generation Biologics 4/30/2026

    HanchorBio Inc., a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and autoimmune diseases, today announced a research collaboration with the College of Engineering Bioscience at National Yang Ming Chiao Tung University (NYCU) to advance AI-enabled biologics discovery.

  4. Huahui Health And BeOne Medicines Enter Into A Global Exclusive Option, License And Collaboration Agreement For Innovative Oncology Drug HH160 4/30/2026

    Huahui Health today announced that it has entered into a global exclusive option, license and collaboration agreement with BeOne Medicines for HH160, a novel trispecific antibody in oncology immunotherapy. Under the agreement, BeOne Medicines is granted an exclusive option covering the development, manufacturing, and commercialization of HH160 worldwide.

  5. U.S. FDA Grants Priority Review Of New Drug Application For Gilead's Once-Daily HIV Treatment Of Bictegravir Plus Lenacapavir 4/29/2026

    Gilead Sciences, Inc. today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed.

  6. Immunome Announces Submission Of New Drug Application To U.S. FDA For Varegacestat For The Treatment Of Adults With Desmoid Tumors 4/29/2026

    Immunome, Inc., a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI), for the treatment of adults with desmoid tumors.

  7. UCLA Research Improves Molecular Probe For Drug Discovery 4/28/2026

    A UCLA-led international research collaboration unveiled a new technology that may help scientists better understand how small molecules, including many drugs, bind to proteins. The invention works with an existing lab method called photo-crosslinking.

  8. BioDuro And CTI Biotechnology Enter Strategic Partnership To Accelerate Preclinical Drug Development 4/28/2026

    BioDuro, a trusted global Contract Research, Development and Manufacturing Organization (CRDMO), today announced a strategic partnership with CTI Biotechnology (Suzhou) Co., Ltd. ("CTI Biotechnology"), a leading provider of preclinical research services for innovative drug development.

  9. BRC Therapeutics Announces Investigational New Drug Application For BRC-002 Cleared By FDA 4/28/2026

    BRC Therapeutics (BRC), a pharmaceutical company developing therapeutics for neurological and inflammatory diseases, announced today that the company can proceed with a Phase I study to further establish safety of BRC-002 in healthy volunteers.

  10. U.S. Food And Drug Administration Accepts New Drug Application For Zipalertinib For The Treatment Of Locally Advanced Or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations 4/28/2026

    Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab.