FDA Approves New RSV Treatment for Infants

FDA approves new RSV treatment for infants

The Food and Drug Administration approved a new vaccine to help protect infants from RSV on Monday.

FDA Grants Fast Track Designation to Nuvisertib in Myelofibrosis

The FDA granted fast track designation to nuvisertib for those with intermediate or high-risk myelofibrosis, which demonstrated symptom relief in patients.

Merck’s Enflonsia to gain competitive advantage in paediatric RSV prophylaxis market with lack of weight-based dosing: GlobalData - Express Pharma

Merck’s Enflonsia (clesrovimab) has received FDA approval for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. Enflonsia, is a long-acting monoclonal antibody (mAb) that can provide protection through a typical 5-month RSV season with a 105mg dose, regardless of weight. This diversifies the prophylactic options available to protect y…

New therapy approved for RSV in kids - WCCB Charlotte's CW

WASHINGTON – The Food and Drug Administration has approved a new monoclonal antibody to protect infants from RSV. The infection is the top cause of infant hospitalization in the U.S. and can be fatal. The therapy, Enflonsia, is made by Merck. It’s given a single 105-milligram shot to protect newborns and infants from RSV through their first virus season. In a mid-to-late stage trial, it reduced RSV associated hospitalizations in infants by more …

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