- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
FDA placed clinical hold on Biomx's Phase 2b trial.
3 reports, 1 independent
Updated Aug 19
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New informationRepeats or wire copies
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What happened
FDA placed clinical hold on Biomx's Phase 2b trial.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA placed a clinical hold on Biomx's Phase 2b trial.1 source
Biomx uses the BOLT platform and is based in Israel.1 source
FDA is reviewing trial plans for BiomX.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
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- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- FDA placed a clinical hold on Phase 2/3 trials for SK Biopharm on September 1, 2026.
- FDA issued a partial clinical hold on trials involving Biohaven Ltd. on September 11, 2026.
- Jazz Pharmaceuticals received FDA approval for a drug following positive clinical trial results.
- TELIX Pharmaceuticals is conducting Phase 3 trials and seeking alignment on the New Drug Application pathway with the FDA.
- SynAct Pharma AB is seeking discussion with the FDA regarding the design of its Phase 3 clinical trials.
Coverage
Newest first; wire copies grouped- GlobeNewswireBiomX Provides Update on BX004 Phase 2b Trial for the Treatment of Patients with Cystic Fibrosis U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on thi
- GlobeNewswireBiomX to Report Second Quarter 2025 Financial Results and Program Updates on August 13, 2025 NESS ZIONA, Israel, Aug. 06, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Co
- GlobeNewswireBiomX Announces Successful Initiation of Phase 2b Trial with First Patient Dosed in BX004 Program in Patients with Cystic Fibrosis First patient dosing in Company’s Phase 2b trial marks pivotal miles