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Results For "clinical-development"

521 News Found

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


Moderna discontinues congenital virus program after Phase 3 trial fails to meet primary endpoint
Clinical Trials | October 23, 2025

Moderna discontinues congenital virus program after Phase 3 trial fails to meet primary endpoint

Vaccine efficacy against primary CMV infection ranged from 6 per cent to 23 per cent, depending on case definition, falling short of Moderna’s predefined target


FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer
Drug Approval | October 23, 2025

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial


AbbVie completes acquisition of Gilgamesh Pharmaceuticals' Bretisilocin
News | October 22, 2025

AbbVie completes acquisition of Gilgamesh Pharmaceuticals' Bretisilocin

Acquisition expands AbbVie's psychiatry pipeline with the addition of a next-generation psychedelic compound currently in Phase 2 development for the treatment of major depressive disorder


Johnson & Johnson’s Rybrevant shows 45% response rate in HNSCC
Clinical Trials | October 22, 2025

Johnson & Johnson’s Rybrevant shows 45% response rate in HNSCC

Based on these promising results, Johnson & Johnson plans to move the program into a Phase 3 trial to further investigate subcutaneous amivantamab


KEYTRUDA + LENVIMA shows durable 5-year survival benefit in advanced endometrial cancer
Clinical Trials | October 22, 2025

KEYTRUDA + LENVIMA shows durable 5-year survival benefit in advanced endometrial cancer

The combination is approved for advanced endometrial carcinoma that is pMMR or not MSI-H and has progressed after prior systemic therapy


Lundbeck and Contera Pharma join forces to advance RNA therapies for neurological disorders
R&D | October 22, 2025

Lundbeck and Contera Pharma join forces to advance RNA therapies for neurological disorders

Contera Pharma will receive an upfront payment and full research funding for each target under investigation


FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease
Drug Approval | October 14, 2025

FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease

Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable


Lupin to present Phase 1 Data on STING agonist at the ESMO Congress 2025
Clinical Trials | October 13, 2025

Lupin to present Phase 1 Data on STING agonist at the ESMO Congress 2025

The presentation will provide qualitative insights into its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with solid tumors