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As RSV Season Approaches, the Federation of Medical Women of Canada Urges National Response to Protect Infants Across the Country
23 Jul 2025 12:24 GMT
Ontario is leading by covering both RSVpreF for pregnant women and pregnant people and nirsevimab for infants, yet provinces like B.C. only cover the older monoclonal antibody, palivizumab, for high-risk infants — leaving 98% of infants unprotected and at …
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Medical experts call for increased awareness and prevention of RSV among infants in India
08 Jul 2025 17:48 GMT
Medical professionals across India are drawing … tools to protect our youngest. Palivizumab has been available for high … .”
Dr Cesar Mascarenas, Head of Medical International Region at Sanofi, added … Dr Bhavesh Kotak, Head of Medical Affairs at Dr Reddy’s …
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FDA News Recap: Novel Drug Approvals in First Half of 2025
02 Jul 2025 18:04 GMT
… 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 …
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FDA Approves Clesrovimab to Prevent RSV in Infants
20 Jun 2025 17:12 GMT
… SMART (MK-1654-007) trials. “ENFLONSIA combines dosing convenience … in incidence of RSV-associated medically attended lower respiratory infections … from the Phase 3 SMART trial (MK-1654-007) … efficacy of ENFLONSIA versus palivizumab in infants at increased …
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MSD’s Enflonsia receives FDA approval for RSV prophylaxis
11 Jun 2025 20:46 GMT
… 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, …
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Merck’s Clesrovimab (Enflonsia) Receives FDA Approval to Protect Infants from RSV During First Season
09 Jun 2025 22:47 GMT
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 …
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FDA Approves Clesrovimab-cfor for Prevention of RSV in Infants
10 Jun 2025 22:14 GMT
… -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, …
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Clesrovimab Wins FDA Approval for Prevention of RSV LRTD in Infants During First RSV Season
10 Jun 2025 17:22 GMT
… 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 …
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FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants
10 Jun 2025 16:48 GMT
… U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ … (MK-1654-007) trials. “ENFLONSIA combines dosing convenience … incidence of RSV-associated medically attended lower respiratory infections … efficacy of ENFLONSIA versus palivizumab in infants at …
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FDA approves clesrovimab to protect infants during first RSV season
09 Jun 2025 23:11 GMT
… 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™ …