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Results For "candidate"

627 News Found

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally


Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate
Clinical Trials | July 26, 2024

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis


BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel
Drug Approval | May 31, 2024

BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel

Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease


Ascentage releases results from multiple clinical studies of its lead drug candidates
Clinical Trials | May 28, 2024

Ascentage releases results from multiple clinical studies of its lead drug candidates

These abstracts report on the company's three lead drug candidates, including olverembatinib


Ascentage Pharma releases latest results from multiple clinical studies of lead drug candidates
News | May 25, 2024

Ascentage Pharma releases latest results from multiple clinical studies of lead drug candidates

Updated results from the four studies will be presented in Oral Reports or Posters at the ASCO Annual Meeting


GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


ARTBIO and PharmaLogic inks supply agreement for Lead-212 based Therapeutic Candidate for  treatment of prostate cancer
Supply Chain | January 15, 2024

ARTBIO and PharmaLogic inks supply agreement for Lead-212 based Therapeutic Candidate for treatment of prostate cancer

PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York


Merck announces Phase 3 trial initiations for 4 Investigational Candidates from hematology and oncology pipeline
Clinical Trials | January 06, 2024

Merck announces Phase 3 trial initiations for 4 Investigational Candidates from hematology and oncology pipeline

Comprehensive clinical development programs being initiated for each investigational candidate


Zydus announces IND clearance of a novel Anti-PCSK9 candidate
Clinical Trials | October 03, 2023

Zydus announces IND clearance of a novel Anti-PCSK9 candidate

Aim is to treat Dyslipidemia by inhibiting PCSK9 with a novel entity