… under the New Drugs and Clinical Trials Rules and … Concizumab, Intas Pharmaceuticals Ltd’s Serplulimab, Sun Pharmaceutical Industries Ltd … mg other medicinal products for the treatment of diabetes … 47;23/000092 Palivizumab Palivizumab is indicated for the …

… 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 …

… IIb/III CLEVER trial (NCT04767373) evaluating a single … Treatment with Enflonsia reduced the incidence of RSV-associated medically attended … of Sobi’s Synagis (palivizumab), an older mAb which … to become a successful drug in the pediatric market, …

… -associated medically attended lower respiratory infection were comparable to palivizumab. “ … on the CLEVER and SMART trials., said in a release … phase 2b/3 trial that evaluated the efficacy … newsletter and get the latest drug information, industry trends, …

… 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™ ( …