Merck, known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration has approved ENFLONSIA™ for the prevention of respiratory syncytial virus lower ...

Merck & Co., Inc. (NYSE:MRK) added that the approval is basis the results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of ENFLONSIA administered to preterm and ...

“Enflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,” Dr. Dean Y. Li, president of Merck Research ...

Merck & Co., Inc. (NYSE:MRK) noted that ENFLONSIA is the first and only RSV preventive option administered to infants using the same dose regardless of weight, simplifying dosing logistics.

Six members of the committee voted to continue to recommend that everyone 6 months and older receive an annual flu vaccine. Pebsworth abstained. Vaccines with thimerosal are still approved by the FDA.

Enflonsia was approved by the FDA in early June. At the time, Merck said it planned to start taking orders in July and would deliver the doses in the U.S. this fall, ahead of the start of the RSV ...

Study materials that Merck submitted to the FDA for its approval showed that the antibody had a similar safety profile as a placebo. The most common adverse reactions from Enflonsia were mild and ...

The shot, called clesrovimab and given the brand name Enflonsia, is made by Merck and joins two other interventions already on the market to protect babies against severe disease from RSV, a ...

“Enflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,” Dr. Dean Y. Li, president of Merck Research ...