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Results For "clinical-data"

185 News Found

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies
R&D | November 28, 2025

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies

GLP-1 therapies are among the fastest-growing drug classes worldwide, projected to drive a $95 billion obesity market by 2030


ImmunoScape inks agreement with Cue Biopharma to launch next-gen cancer immunotherapy
Biopharma | November 16, 2025

ImmunoScape inks agreement with Cue Biopharma to launch next-gen cancer immunotherapy

The modular platform not only targets solid tumors but could also enhance traditional autologous and in vivo T cell therapies


Johnson & Johnson gets FDA nod for new depression treatment
Drug Approval | November 10, 2025

Johnson & Johnson gets FDA nod for new depression treatment

This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials


Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'
Drug Approval | November 10, 2025

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases


Sumitomo Pharma America unveils promising new leukemia and myelofibrosis data ahead of ASH 2025
Clinical Trials | November 06, 2025

Sumitomo Pharma America unveils promising new leukemia and myelofibrosis data ahead of ASH 2025

Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis


Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success
Clinical Trials | October 31, 2025

Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success

ADX-248, which replaces ADX-743, is being developed for the treatment of metabolic inflammation, including obesity and hypertriglyceridemia


Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions
Clinical Trials | October 31, 2025

Alexion highlights breakthrough C5 inhibition advances in gMG at 2025 AANEM and MGFA scientific sessions

New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris


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


FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder
Drug Approval | October 11, 2025

FDA approves Teva’s expanded indication for Uzedy for bipolar I disorder

UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults