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Results For "safety"

1408 News Found

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


Merieux completes acquisition of Bureau Veritas' food testing activities in Canada and US
News | January 10, 2025

Merieux completes acquisition of Bureau Veritas' food testing activities in Canada and US

The transaction is part of a broader agreement with Bureau Veritas covering its worldwide food laboratory testing activities


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


Windlas Biotech’s new injectable facility receives GMP certification
News | January 10, 2025

Windlas Biotech’s new injectable facility receives GMP certification

The certification marks a new chapter in Windlas Biotech’s growth trajectory,


Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107
Clinical Trials | January 09, 2025

Suven Life Sciences announces first subjects dosed in phase-1 clinical trial of SUVN-I6107

The primary objective of the study is to assess the safety and tolerability of SUVN-I6107 by monitoring adverse events (AEs), clinical laboratory, vital signs and electrocardiographs


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


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


Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation
Digitisation | January 07, 2025

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client


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


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