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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 Enflonsia receives US FDA approval for prevention of RSV lower respiratory tract disease in infants born during or entering their first RSV season
11 Jun 2025 03:33 GMT
… US Food and Drug Administration (FDA) has approved Enflonsia … (MK-1654-007) trials. “Enflonsia combines dosing … with RSV-associated medically attended lower respiratory infection … partially-blind, palivizumab-controlled, multi-site trial to evaluate the …
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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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FDA Approves Clesrovimab to Prevent RSV in Infants During First Season
11 Jun 2025 01:45 GMT
… 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- …
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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 clesrovimab for preventing RSV in infants
10 Jun 2025 22:18 GMT
… Healio
Key takeaways:
The FDA approved the monoclonal antibody … brand name Enflonsia.
The FDA approved clesrovimab for the … trial in which one dose of clesrovimab reduced RSV-associated medically … compared with five doses of palivizumab — an mAb that has …
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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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Merck’s RSV monoclonal antibody Enflonsia approved by FDA to protect infants
10 Jun 2025 12:38 GMT
… 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 …
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MSD receives FDA approval for Enflonsia to prevent RSV
10 Jun 2025 10:57 GMT
… US Food and Drug Administration (FDA) approval for … efficacy in reducing medically attended lower respiratory … trial, in which Enflonsia’s safety profile was assessed against palivizumab … for the prestigious Pharmaceutical Technology Excellence Awards …
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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 …