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  • PRAN Virtual Undergraduate Phage Research Symposium 2026: call for abstractsOct 23, 2026

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Ep 18: Discussion of Phage Therapy for CF Patients - Rebekah Dedrick

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  1. EventsOct 1, 2026

    European Medicines Agency workshop on bacteriophage therapy

    Workshop at the European Medicines Agency in Amsterdam, with online participation, on Friday 30 October 2026, 09:00 to 18:00 Amsterdam time (CET). It brings together regulators, policymakers, scientists, healthcare professionals, developers

    EventsWorkshopRegulationPhage Therapy
  2. NewsSep 14, 2026

    FDA grants Breakthrough Therapy designation to Armata’s AP-SA02 for complicated S. aureus bacteremia

    Armata Pharmaceuticals announced on September 14, 2026 that the US FDA has granted Breakthrough Therapy designation to AP-SA02, its intravenous multi-phage product candidate for adjunct treatment of complicated Staphylococcus aureus bactere

    NewsRegulationClinical TrialsPhage Therapy
  3. NewsJan 13, 2026

    Armata announces FDA End-of-Phase 2 response and plan to advance phage cocktail AP-SA02 to a Phase 3 superiority study in complicated S. aureus bacteremia

    Armata Pharmaceuticals announced on January 13, 2026 an FDA End-of-Phase 2 written response confirming that safety and efficacy data from its Phase 2a diSArm study support advancing AP-SA02, an intravenous S. aureus bacteriophage cocktail,

    NewsRegulationClinical TrialsPhage Therapy
  4. NewsOct 24, 2025

    EMA draft guideline on quality aspects of phage therapy medicinal products

    The European Medicines Agency's draft guideline on quality aspects of phage therapy medicinal products (EMA/CHMP/BWP/1/2024) clarifies the regulatory expectations for quality documentation of bacteriophage active substances and finished pro

    NewsRegulationManufacturing
  5. NewsOct 16, 2025

    TGA consults on a proposed GMP exemption for personalised bacteriophage manufacture in Australia

    Australia's Therapeutic Goods Administration consulted on a proposed time-limited GMP exemption for manufacturers of personalised bacteriophage therapy products, which are currently supplied as unapproved goods under the Special Access Sche

    NewsRegulationPhage TherapyManufacturing
  6. NewsAug 25, 2025

    Cytophage receives Health Canada Letters of No Objection for OvaPhage and PhageFend food-safety phage products

    Cytophage Technologies announced on August 25, 2025 that it received two Letters of No Objection from Health Canada's Food Directorate for its OvaPhage egg-surface and PhageFend food-surface bacteriophage products. According to the company,

    NewsFood SafetyRegulationIndustry
  7. NewsAug 19, 2025

    FDA places clinical hold on BiomX Phase 2b study of BX004 in cystic fibrosis over a third-party nebulizer

    In a Form 8-K dated August 19, 2025, BiomX reported that the FDA placed a clinical hold on its Phase 2b study of BX004 in cystic fibrosis while it reviews data on a third-party nebulizer used to deliver BX004. The FDA raised no concerns abo

    NewsRegulationClinical TrialsPhage Therapy
  8. NewsJun 4, 2025

    MHRA publishes the UK's first official guidance on developing phage therapies

    On 4 June 2025 the UK Medicines and Healthcare products Regulatory Agency (MHRA) published the UK's first official guidance to support the safe development and use of phage therapies, covering both combined phage products for common infecti

    NewsRegulationPhage Therapy
  9. NewsNov 15, 2024

    INFARMED approves guidance on hospital-pharmacy magistral preparations of bacteriophages for individual patients (Deliberação 112/CD/2024)

    On 15 November 2024 the board of Portugal's medicines authority INFARMED approved, in Deliberação n.º 112/CD/2024, a guidance note on compounded medicines for phage therapy in hospitals: magistral preparations of bacteriophages made in a ho

    NewsRegulationPhage Therapy
  10. UpdatesJul 5, 2023

    PhageEurope (Phage EU) is a new coalition of likeminded stakeholders who represent phages in industry, the scientific communi

    PhageEurope (Phage EU) is a new coalition of likeminded stakeholders who represent phages in industry, the scientific community and civil society who wants to realize the full potential of phages in Europe. They are holding a webinar 11 Jul

    UpdatesCommunityWebinarPhage therapyRegulation
  11. UpdatesNov 27, 2020

    The WHO's 4th Clinical Antibacterial Pipeline Advisory Group Meeting took place this week. Haileyesus Getahun, MD (Joint Secr

    The WHO's 4th Clinical Antibacterial Pipeline Advisory Group Meeting took place this week. Haileyesus Getahun, MD (Joint Secretariat on AMR at WHO) stated via Twitter that for the first time, available data on phage therapy was set to be ev

    UpdatesNewsPhage TherapyRegulation
  12. UpdatesSep 25, 2020

    An international team of scientists are calling for the European Union to enforce non-animal antibody production, and phage d

    An international team of scientists are calling for the European Union to enforce non-animal antibody production, and phage display may be the ideal replacement. Report | Press release.

    UpdatesPhage displayRegulation
  13. UpdatesNov 15, 2019

    One of Intralytix's phage products, EcoShield (which targets E. coli O157:H7), has been approved by the FDA to be used more b

    One of Intralytix's phage products, EcoShield (which targets E. coli O157:H7), has been approved by the FDA to be used more broadly. Now it can be used on ground beef (plus other meat cuts and on carcasses). Previously, it could only be use

    UpdatesBiotechPhages in foodRegulation
  14. UpdatesNov 13, 2019

    One of Intralytix's phage products, EcoShield (which targets E. coli O157:H7), has been approved by the FDA to be used more b

    One of Intralytix's phage products, EcoShield (which targets E. coli O157:H7), has been approved by the FDA to be used more broadly. Now it can be used on ground beef (plus other meat cuts and on carcasses). Previously, it could only be use

    UpdatesBiotechPhages in foodRegulation
  15. Events

    STOA workshop: Phage therapy as a tool against antimicrobial resistance

    STOA workshop at the European Parliament in Brussels on 30 September 2026 on advancing phage therapy as an evidence-based strategy against antimicrobial resistance, with attention to regulatory, clinical and practical hurdles and to multidr

    EventsWorkshopPhage TherapyRegulation
  16. News

    UK Commons committee inquiry: the antimicrobial potential of bacteriophages

    The House of Commons Science, Innovation and Technology Committee ran an inquiry into the antimicrobial potential of bacteriophages, prompted by a pitch to its My Science inquiry and asking how UK and EU regulation, which has largely limite

    NewsRegulationPhage Therapy
  17. News

    Arrowsmith completes ¥1.05 billion Series A and FDA pre-IND meeting for phage cocktail ARW001

    Arrowsmith (Tsukuba, Japan) completed a Series A round totaling ¥1.05 billion, with JAFCO, JIC-VGI and ANRI in the first close and DBJ Capital in the second, and held a pre-IND meeting with the US FDA on ARW001, its phage cocktail for Pseud

    NewsFundingRegulationPhage Therapy
  18. News

    Abstract book gathers contributions from Targeting Phage Therapy 2026

    The official abstract book for the 9th World Conference on Targeting Phage Therapy includes over 48 contributions from 24 countries. Topics include phage therapy, One Health, and production, regulation and market access. Targeting Phage The

    NewsToolsPhage TherapyOne HealthRegulation
  19. News

    ASM Health launches a PTCN regulatory working group

    A second ASM Health Phage Therapy Coordination Network working group focuses on regulatory pathways and implementation resources for patient access. People with relevant experience were invited to apply. Dev Mittar — original commentary

    NewsPhage TherapyRegulation
  20. News

    UK Commons committee report on bacteriophages recommends exploring a shared GMP facility for phage production

    The House of Commons Science, Innovation and Technology Committee's report The antimicrobial potential of bacteriophages follows an inquiry that received over 40 pieces of written evidence and held three oral evidence sessions. Among its re

    NewsRegulationManufacturing
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