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News about "Phase 3 clinical trial"
EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke
The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.
Phase 3 Clinical Trial | 11/06/2026 | By News Bureau | 110
US FDA Grants Priority Review to Zydus Therapeutics' Saroglitazar for Primary Biliary Cholangitis
Zydus Therapeutics has received US FDA Priority Review (PR) for its New Drug Application (NDA) for saroglitazar in the treatment of Primary Biliary Cholangitis (PBC), supported by phase 3 EPICS-III trial results demonstrating significant biochemical response, with detailed data to be presented at the EASL Congress 2026.
Phase 3 Clinical Trial | 29/05/2026 | By News Bureau
Caliway Biopharmaceuticals secures US FDA IND clearance for CBL-0302, a global phase 3 clinical trial evaluating CBL-514 for non-surgical abdominal fat reduction.
Phase 3 Clinical Trial | 28/05/2026 | By News Bureau
Regenxbio Reports Positive Pivotal Trial Results for Duchenne Gene Therapy RGX-202
Regenxbio’s investigational gene therapy RGX-202 demonstrated strong microdystrophin expression, functional gains and a favourable safety profile in Duchenne muscular dystrophy patients, supporting plans for accelerated approval and a potential commercial launch in 2027.
Phase 3 Clinical Trial | 15/05/2026 | By News Bureau
Alebund Pharmaceuticals has completed patient enrollment in its global phase 3 RESPOND-2 study evaluating AP301, a next-generation phosphate binder for CKD patients on dialysis.
Phase 3 Clinical Trial | 07/05/2026 | By News Bureau | 115
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