Poolbeg Pharma Gets FDA Support for POLB 001 Drug

Poolbeg Pharma gets FDA support for POLB 001 drug

Biopharmaceutical company Poolbeg Pharma said the US Food and Drug Administration has granted Orphan Drug Designation (ODD) to its POLB 001 product as an oral preventative therapy for Cytokine Release Syndrome (CRS).

Novel CRS Prevention Therapy Granted FDA Orphan Drug Designation

POLB 001 has been granted FDA orphan drug designation as a preventative therapy for cytokine release syndrome caused by bispecific antibody therapy.

Poolbeg Pharma plc – Poolbeg granted FDA Orphan Drug Designation for POLB 001 – Optimum Strategic CommunicationsLink to: Poolbeg Pharma plc – Annual Report, AGM Notice & CircularLink to: Heidelberg Pharma Announces First Patient Dosed in Phase I Study of

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…

Poolbeg Pharma PLC (AIM:POLB) FDA Orphan Drug Designation granted for POLB 001

Share via: Facebook X LinkedIn WhatsApp Pocket Messenger Copy Link Telegram Email More Poolbeg Pharma PLC (AIM: POLB) has received a significant regulatory endorsement from US authorities for one ofRead More...