Last edition
News about "Phase 3 clinical trial"
Merck's Tulisokibart Met Primary and Key Secondary Endpoints in Phase 3 ATLAS-UC Induction
Merck’s tulisokibart achieved both primary and key secondary endpoints in the phase 3 ATLAS-UC induction study, demonstrating significant efficacy in patients with moderately to severely active Ulcerative Colitis (UC).
Phase 3 Clinical Trial | 23/06/2026 | By News Bureau
US FDA Approves Utebzi for Adult Patients with Complicated UTIs
The US Food and Drug Administration (FDA) has approved GSK’s Utebzi (tebipenem pivoxil) for adults with complicated Urinary Tract Infections (cUTIs), becoming the first and only oral carbapenem antibiotic available. The approval is based on the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to standard intravenous antibiotic treatment.
Phase 3 Clinical Trial | 19/06/2026 | By News Bureau
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 | 134
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 | 118
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy