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Results For "Risk"

1411 News Found

Dr. Jitendra Singh inaugurates 'National Biobank' at CSIR-IGIB
Policy | July 07, 2025

Dr. Jitendra Singh inaugurates 'National Biobank' at CSIR-IGIB

CSIR-IGIB advances indigenous CRISPR Trials on sickle cell anaemia, anti-microbial resistance, liver fibrosis and rare disorders


Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone


Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer
Clinical Trials | July 06, 2025

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone


INmune Bio reports core findings from Phase 2 trial in early Alzheimer’s disease
Clinical Trials | July 02, 2025

INmune Bio reports core findings from Phase 2 trial in early Alzheimer’s disease

Treatment with XPro was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients


EMA starts review of sodium oxybate in alcohol dependence
Policy | June 28, 2025

EMA starts review of sodium oxybate in alcohol dependence

Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse


FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels
Drug Approval | June 28, 2025

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


Covestro launches localized production of medical-grade TPU in Asia Pacific
Medical Device | June 25, 2025

Covestro launches localized production of medical-grade TPU in Asia Pacific

Changhua site meets international regulatory standards for global medical applications


Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Clinical Trials | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy


AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study
Clinical Trials | June 21, 2025

AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month