News
Fulcrum Therapeutics Announces Results from the 12 mg Dose Cohort of the  Phase 1b PIONEER Trial of Pociredir in Sickle Cell Disease
Clinical ResultFast TrackOrphan Drug
Calidi Biotherapeutics Receives FDA Fast Track Designation for CLD-201 (SuperNova), a First-In-Class Stem-Cell Loaded Viral Therapy for the Treatment of Patients with Soft Tissue Sarcoma
Fast Track
Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the 2025 World Conference on Lung Cancer
ImmunotherapyFast Track
Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies and Alzheimer’s Disease
Clinical ResultFast Track
EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration
Clinical ResultDrug Approval
AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
ImmunotherapyClinical ResultOrphan Drug
UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology
Clinical ResultDrug Approval
Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
ImmunotherapyIND
LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia
NDALicense out/inClinical Result
Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis
Clinical ResultNDA