Seven FDA approval decisions to watch in June

At least seven PDUFA dates are on FDA’s docket in June, including two new approaches to disease prevention.

Both preventative products offer less frequent dosing than approved competitors. Merck & Co. Inc. (NYSE:MRK) is seeking approval of clesrovimab to prevent RSV infection in infants. Merck’s mAb is given just once during a baby’s first RSV season, while approved mAb Synagis palivizumab from Swedish Orphan Biovitrum AB (SSE:SOBI) is dosed monthly. ...