… of Medical Research (ICMR), several central procurement bodies, and pharmaceutical industry … , Tremelimumab, Brentuximab Vedotin, and Palivizumab, along with next-generation therapies … the inclusion of any drug by demonstrating local manufacturing capability …

… and pneumonia.1 Preventive treatments for RSV in infants … a safety profile comparable to palivizumab while allowing efficacy to … well tolerated. In clinical trials, the most common adverse … 47;/www.accessdata.fda.gov/drugsatfda_docs/label…

… medical community, with 16 novel drug approvals signaling major strides in disease treatment … trials of acute surgical pain, with one trial … .002). Related Coverage: FDA Approves Nipocalimab Generalized Myasthenia … of ENFLONSIA versus palivizumab in infants at …

The US Food and Drug Administration (FDA) has approved Merck’s clesrovimab ( … treatment demonstrated strong efficacy in pivotal Phase 2b/3 trials,reducing medically … ongoing Phase 3 SMART trial, comparing enflonsia to palivizumab in infants at …

… FDA based its approval on data from 2 key phase 3 trials … trial (N = 3,614), clesrovimab reduced the incidence of RSV-associated medically … phase 3 SMART trial (N=896) compared clesrovimab to palivizumab in high …

… trial (MK-1654-007) evaluating safety and efficacy of clesrovimab vs palivizumab … of RSV-associated medically attended lower respiratory infections … 90.9% with clesrovimab treatment compared to placebo … References: 1. US FDA Approves Merck’s ENFLONSIA™ …

… and efficacy of ENFLONSIA versus palivizumab in infants at increased … 2 In CLEVER, the trial met its primary end point … the incidence of RSV-associated medically attended lower respiratory infections … systems.” REFERENCE U.S. FDA Approves Merck’s ENFLONSIA™ ( …

… incidence of RSV-associated medically attended lower respiratory infections … and rash, with no treatment-related deaths reported. “RSV … CLEVER and SMART (NCT04938830) trials, said in a statement. … and compared clesrovimab against palivizumab.4 Rates of RSV- …

… the US Food and Drug Administration (FDA) for use in … incidence of RSV-associated medically attended lower respiratory infections … phase 3 SMART trial comparing Enflonsia against palivizumab, another RSV … the CLEVER and SMART trials. The US Centers for …

… Trials and Data Supporting U.S. FDA Approval The CLEVER trial … was generally comparable to palivizumab and consistent with the … advance the prevention and treatment of diseases in people … fluctuations; the impact of pharmaceutical industry regulation and health …