Record mula sa primary source
MateryalIba pa
United Therapeutics nakakuha ng clearance mula sa FDA para sa UHeart xenotransplant trial
FDA cleared the company’s IND to begin the EXPRESS clinical study of the 10-gene-edited UHeart in up to two initial participants. The study is designed as a seamless Phase 1/2/3 trial intended to generate data supporting a future BLA submission. Enrollment of the second participant and any expansion will be gated on FDA review of safety and efficacy data from the preceding transplants.
Mahahalagang fact
- Na-file
- May 15, 2026, 10:00 PM
- Kaganapan
- Iba pa
- Direksyon
- Positibo
- Kumpanya
UTHRUnited Therapeutics- Asset
- UHeart
- Pinagmulan
- Press release ng kumpanya
- Kumpiyansa
- May source
Sipi mula sa source
United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial First-ever human clinical trial of a xenoheart intended to support potential registration through the submission of a Biologics License Application to the U.S. FDA United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration ( FDA ) has granted clearance under the company’s Investigational New Drug application to proceed with a clinical study of its investigational UHeart™