Current Headlines

1. ASG Receives U.S. FDA IND Approval To Initiate Phase 1 Clinical Trial Of The Lead Drug Beta1 For Male Erectile Dysfunction 12/17/2025

   Asia Scientific Global Inc. (ASG), a leader in the research and development of novel inhaled drugs, today announced that its lead product, Beta1, has received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA).

2. Harbour Biomed Enters Into Global Strategic Collaboration And License Agreement With Bristol Myers Squibb To Discover And Develop Next-Generation Multi-Specific Antibodies 12/16/2025

   Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a multi-year, global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multi-specific antibodies.

3. Recludix Pharma Announces FDA Clearance Of Investigational New Drug Application For REX-8756, An Oral STAT6 Inhibitor, To Enter Into The Clinic 12/16/2025

   Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application to advance REX-8756, an oral STAT6 inhibitor, into Phase 1 clinical testing.

4. Fortress Biotech And Cyprium Therapeutics Announce FDA Acceptance Of CUTX-101 NDA Resubmission 12/15/2025

   Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients.

5. Immusoft Secures FDA Orphan Drug Designation For ISP-002 In MPS II, A Progressive Lysosomal Storage Disease 12/15/2025

   Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ISP-002, the Company's investigational engineered B cell therapy for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, a rare and life-threatening lysosomal storage disorder.

6. This New, One-Two Punch Could Knock Out Drug-Resistant TB 12/12/2025

   Tuberculosis is both curable and preventable, yet each year, it still kills more people than any other infectious disease. One reason is that current treatments hinge on rifampicin, an antibiotic that blocks bacterial transcription and forms the cornerstone of a multidrug regimen—and rising drug resistance has revealed the limits of leaning so heavily on a single point of attack.

7. UMBC Discovery Opens Door To Broad-Spectrum Antivirals Against Dozens Of Dangerous Viruses 12/12/2025

   A study out of UMBC, published in Nature Communications, reveals how enteroviruses—including pathogens that cause polio, encephalitis, myocarditis, and the common cold—initiate replication by hijacking host-cell machinery.

8. Phare Bio And Basilea Announce Landmark Partnership To Develop Next-Generation Broad-Spectrum Antibiotic Using AI 12/11/2025

   Phare Bio, a biotech social venture harnessing artificial intelligence to accelerate antibiotic discovery and development, and Basilea Pharmaceutica, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today a strategic partnership to jointly develop a novel broad-spectrum antibiotic to address critical unmet needs for patients battling life-threatening infections caused by high-priority gram-negative pathogens.

9. Basilea And Phare Bio Enter Partnership Combining Anti-Infectives Industry Expertise With Unique AI Capabilities For The Development Of A Novel Antibiotic 12/11/2025

   Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today a partnership with Phare Bio Inc., Boston (USA), a biotech social venture that uses Artificial Intelligence (AI) to accelerate antibiotic discovery and development.

10. Inotiv Partners With VUGENE To Advance AI-Driven Drug Discovery And Bioinformatics Capabilities 12/11/2025

    Inotiv, Inc. (NASDAQ: NOTV) (the “Company”, or “Inotiv”), a leading Contract Research Organization (CRO) specializing in nonclinical and analytical drug discovery and development services and research models and related products and services, and VUGENE, a multi-omics data analysis company providing advanced artificial intelligence (AI) and machine learning (ML) solutions for biomedical research, today announced a strategic collaboration designed to accelerate AI-assisted drug discovery and enhance data-driven insights across the drug development continuum.