FDA to review GSK's rotavirus vaccine

The feds have agreed to consider allowing GlaxoSmithKline to sell its rotavirus vaccine, Rotarix, in the U.S. Already licensed in nearly 100 countries, Rotarix is designed to protect children from the virus, which can cause severe diarrhea and dehydration. It would compete against RotaTeq, Merck's product, which is already approved for sale. Several medical societies and the U.S. government recommend that all infants receive rotavirus vaccinations.

- see this release
- here's the report from the Triangle Business Journal
- and here's the AP report

Suggested Articles

Post-Tesaro buyout, don’t expect GlaxoSmithKline to spring for more commercial-stage oncology products anytime soon.

Already a fast-growing blockbuster, Novo Nordisk's injectable Ozempic won a major heart-helping FDA nod that could bode well for its oral sibling.

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.