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Results For "clinical-development"

616 News Found

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy
Drug Approval | February 13, 2025

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries


AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma
News | January 17, 2025

AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma

SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Steven R. Smith joins Zealand Pharma as Senior Global Medical Advisor in Obesity
People | January 13, 2025

Steven R. Smith joins Zealand Pharma as Senior Global Medical Advisor in Obesity

Dr. Smith brings 30 years of clinical and translational research experience in obesity, diabetes, and metabolism with over 300 scientific publications


Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies
Clinical Trials | January 10, 2025

Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

QUANTI clinical development program evaluated the efficacy and safety of the investigational MRI contrast agent gadoquatrane for a broad range of potential indications and in pediatric and adult patients


Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of vasomotor symptoms caused by breast cancer treatments
Clinical Trials | January 09, 2025

Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of vasomotor symptoms caused by breast cancer treatments

The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life


FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections
Drug Approval | January 02, 2025

FDA grants orphan drug designation to MicuRx's MRX-5 for non-tuberculous mycobacteria infections

MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria


Merck to discontinue KeyVibe and Keyform clinical trials
Clinical Trials | December 17, 2024

Merck to discontinue KeyVibe and Keyform clinical trials

Merck has also decided to end the favezelimab clinical development program


Merck announces FDA acceptance of biologics license application for Clesrovimab
Drug Approval | December 17, 2024

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season


Lynparza demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase 3 trial
Clinical Trials | December 12, 2024

Lynparza demonstrated clinically meaningful prolonged survival benefit in early breast cancer in OlympiA Phase 3 trial

First and only PARP inhibitor to improve overall survival in early breast cancer