News about "Phase 3 clinical trial"

Sobi and Innate Pharma Partner to Advance Lacutamab in T-Cell Lymphoma

Sobi and Innate Pharma partners to advance lacutamab into the TELLOMAK-3 Phase 3 trial, supporting its potential accelerated approval in Sézary syndrome and future development across cutaneous T-cell lymphoma.

Phase 3 Clinical Trial | 10/08/2026 | By News Bureau

Gilead and Merck Report Positive Phase 3 Results for Investigational Once-Weekly Oral HIV Therapy

ISLEND-1 and ISLEND-2 trials demonstrate non-inferior efficacy and favourable safety profile, supporting regulatory submissions for what could become the first once-weekly oral HIV treatment.

Phase 3 Clinical Trial | 22/07/2026 | By News Bureau

Opus Genetics Aligns with US FDA on Phase 3 OPGx-LCA5 Trial

Opus Genetics has aligned with the US Food and Drug Administration (FDA) on the Phase 3 trial design for OPGx-LCA5 in inherited retinal disease, with phase 3 dosing expected in Q4 2026 and a potential Biologics License Application (BLA) submission based on 6-month efficacy data.

Phase 3 Clinical Trial | 07/07/2026 | By News Bureau |  109

Glenmark Advances Global Phase 3 Trial of HER2-Targeted ADC for Platinum-Resistant Ovarian Cancer

Glenmark Specialty has initiated patient enrolment in India for the Phase 3 trial of trastuzumab rezetecan, aiming to expand treatment options for patients with platinum-resistant ovarian cancer across its licensed global markets.

Phase 3 Clinical Trial | 04/07/2026 | By News Bureau |  111

Newron Provides Update Following Type A Meeting with the US FDA

Newron has provided an update following its Type A meeting with the US Food and Drug Administration (FDA), outlining the steps required to resume US enrollment in the phase 3 ENIGMA-TRS 2 schizophrenia study.

Phase 3 Clinical Trial | 04/07/2026 | By News Bureau |  146

Roche's Divarasib Outperforms KRAS G12C Inhibitors in Phase 3 NSCLC Trial

Roche’s divarasib demonstrated superior Progression-Free Survival over approved KRAS G12C inhibitors in the phase 3 Krascendo-1 trial for previously treated advanced Non-Small Cell Lung Cancer (NSCLC).

Phase 3 Clinical Trial | 02/07/2026 | By News Bureau

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 |  371

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 |  117

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 |  191

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 |  134