GSK today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for FLULAVAL® QUADRIVALENT (Influenza Vaccine). This vaccine is currently approved for active immunisation against influenza A subtype viruses and type B viruses, in persons three years of age and older.
Leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections
GSK [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration approved an expanded age indication for HIBERIX® [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]. HIBERIX® is now indicated for the immunization of children aged six weeks through four years (prior to 5th birthday) against invasive disease caused by Haemophilus influenzae type b (Hib). Hib infection is a serious disease caused by bacteria usually affecting children under the age of five, and Hib vaccination for appropriate children is routinely recommended.
ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, today formalised its collaboration with Janssen Sciences Ireland UC (Janssen) for the phase III investigation and commercialisation of the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV-1 infection.