Tag Archive for: FDA

Hansa Biopharma announces submission of IND Application to US FDA for HNSA-5487 in GBS

The IND submission marks an important milestone in advancing Hansa’s novel IgG-cleaving enzyme into clinical development in GBS. Lund, Sweden, October 20, 2026. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announced that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for HNSA-5487, Hansa’s novel IgG-cleaving […]

Currus Biologics announces FDA IND clearance for Phase 1 trial of CUR-001 in mesothelin-positive advanced refractory solid tumours

The first clinical programme from Currus’ BEAT platform, designed to overcome the barriers that have limited CAR T-cell therapy in solid tumours CUR-001 combines CURB-001, Currus’ BEAT bispecific antibody, with CURT-001, its FLAG-tagged autologous anti-mesothelin CAR T-cell therapy The open-label basket study will enrol patients with mesothelin-positive advanced refractory solid tumours, with the first patient […]

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational New Drug (IND) clearance Recent positive interim results showed safety and immunogenicity with early signals of activity Full week-100 results from Part 1 of VacSYn trial expected in H2 2026   Lausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), […]

Poolbeg Pharma plc – pre-IND meeting with the FDA for POLB 001

FDA feedback supports Poolbeg’s proposed development pathway for POLB 001, providing further clarity for ongoing partnering discussions 26 May 2026- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces the positive outcome of a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug […]

PDUFA Action Date for Hansa Biopharma’s Imlifidase BLA Set for December 19, 2026

If approved, imlifidase will be the first treatment to address highly sensitized patients awaiting kidney transplantation. Lund, Sweden, 4 March 2026. Hansa Biopharma AB, (“Hansa” or “the Company”), (Nasdaq Stockholm: HNSA), today announced that the Food and Drug Administration (FDA) has notified the company that the previously accepted Biologics License Application (BLA) for imlifidase has been […]

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