April’s CHMP opinions include GSK’s RSV vaccine, three cancer drugs

EMA’s CHMP has recommended approval of five new medicines and label expansions for 10 previously approved medicines.

Among the five newly recommended for approval is respiratory syncytial virus vaccine Arexvy from GSK plc (LSE:GSK; NYSE:GSK). In a March 1 meeting, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBAC) showed more enthusiasm for GSK’s RSV vaccine than it did for a competing vaccine from Pfizer Inc. (NYSE:PFE), although both received overall positive votes. Both vaccines have PDUFA dates in May, with Arexvy’s on May 3. GSK CSO Tony Wood discussed the company’s product in December on The BioCentury Show...