Tag Archive for: FDA

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

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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), […]

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

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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…

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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)

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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 […]

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Alys Pharmaceuticals Announces Dosing of First Patient in Phase IIa Trial of ALY-101 for Alopecia Areata

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Unique siRNA platform, developed with Nobel Prize Laureate Craig Mello, offers potential for treating multiple dermatology indications  ALY-101 is formulated as an intradermal injectable for the treatment of Alopecia Areata Health Authorities in Canada and the United States provided swift CTA & IND approval allowing for efficient dosing of the first patients Boston, Massachusetts and […]

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U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy

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225Ac-satoreotide is a first-in-class Actinium-labelled somatostatin receptor 2 antagonist targeting extensive-stage Small Cell Lung Cancer or Merkel Cell Carcinoma Orphan Drug Designation follows outstanding preclinical data and FDA IND clearance Phase I/II human trials set to commence in Q1 2025 as a ‘theranostic’ targeted radionuclide treatment Berlin, Germany, 6 February 2025 – Ariceum Therapeutics (Ariceum), a […]

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