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Results For "Phase-1-study"

55 News Found

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease


AllRock Bio raises $50 million to drive therapy for pulmonary hypertension into phase 2 trials
Clinical Trials | September 19, 2025

AllRock Bio raises $50 million to drive therapy for pulmonary hypertension into phase 2 trials

Funding supports development of first-in-class pan-ROCK inhibitor ROC-101 through Phase 2a clinical testing


FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers
Drug Approval | September 16, 2025

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo


FDA lifts hold on Rocket Pharma's gene therapy trial
News | August 22, 2025

FDA lifts hold on Rocket Pharma's gene therapy trial

Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort


BioAge Labs doses first patient in BGE-102 phase 1 trial
Biotech | August 19, 2025

BioAge Labs doses first patient in BGE-102 phase 1 trial

The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants


Everest Medicines progresses in AI-powered mRNA platform at 2025 R&D day
News | July 08, 2025

Everest Medicines progresses in AI-powered mRNA platform at 2025 R&D day

The company showcased three core programs developed through this platform


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


Glenmark Pharma reports Q3 FY25 PAT at Rs. 348 Cr
News | February 17, 2025

Glenmark Pharma reports Q3 FY25 PAT at Rs. 348 Cr

Glenmark’s consolidated revenue was at Rs. 3,387.6 crore as against Rs. 2,506.7 crore recording an increase of 35.1% YoY


Innovent inks agreement with Roche for Novel DLL3 ADC
News | January 02, 2025

Innovent inks agreement with Roche for Novel DLL3 ADC

Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009


Suven Life Sciences announces FDA acceptance of investigational new drug
Drug Approval | August 30, 2024

Suven Life Sciences announces FDA acceptance of investigational new drug

First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects