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Results For "Risk-Evaluation-and-Mitigation-Strategy"

7 News Found

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


Bristol Myers Squibb showcases cardiovascular portfolio at AHA Scientific Sessions 2024
News | November 14, 2024

Bristol Myers Squibb showcases cardiovascular portfolio at AHA Scientific Sessions 2024

Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS


UBC acquires Examoto
Biotech | August 02, 2022

UBC acquires Examoto

With this acquisition, UBC provides the most comprehensive REMS services and innovative risk mitigation solutions for the biopharmaceutical industry


Camzyos is the first and only USFDA-approved cardiac myosin inhibitor
Biotech | April 29, 2022

Camzyos is the first and only USFDA-approved cardiac myosin inhibitor

Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo


USFDA grants distinct indication for Chronic Sleep Disorder
Drug Approval | August 13, 2021

USFDA grants distinct indication for Chronic Sleep Disorder

Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder