Tag Archive for: FDA

Hansa Biopharma Reports Fourth Quarter and Full-Year 2025 Financial Results

· Strong Q4 with 76.0 MSEK in revenue, up 135% from Q4 2024. · Submission of Biologics License Application (BLA) for imlifidase for highly sensitized patients awaiting kidney transplantation. · Successfully completed a directed share issue raising 671.5 MSEK (~ $71.3M). Lund, Sweden, 11 February 2026. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announced its […]

Tulyp Medical emerges from Sofinnova’s medtech accelerator and announces FDA submission following initial first-in-human use

Company unveils patented technology designed to help maintain healthy blood flow during vascular procedures Backed by Sofinnova MD Start and led by experienced medtech entrepreneurs and cardiologists PARIS, France – November 4, 2025 – Tulyp Medical, a Paris-based startup developing a medical device  for intelligent pressure-driven perfusion, emerged from stealth and announced it has submitted […]

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support expedited development and review Ladenburg, Germany, 23 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), […]

Poolbeg Pharma plc – Poolbeg granted FDA Orphan Drug Designation for POLB 001

27 May 2025 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical-stage biopharmaceutical company focussed on the development of innovative medicines to address unmet medical needs, announces that the US Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to POLB 001 as an oral preventative therapy for T-cell engager bispecific antibody-induced Cytokine Release Syndrome (“CRS”). Read more…

Kaerus Bioscience’s lead candidate KER-0193 granted Orphan Drug Designation and Rare Pediatric Drug Designation by U.S. FDA for treatment of Fragile X syndrome (FXS)

FDA’s two designations demonstrate KER-0193’s potential as a treatment for FXS Follows the successful completion of Phase 1 clinical trial Fragile X syndrome is the most common cause of inherited autism London, UK, 14 May 2025 – Kaerus Bioscience (“Kaerus” or “the Company”), a clinical stage biopharmaceutical company created by Medicxi for the development of […]