FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases

June 22, 2018 – On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine. The application is seeking approval for an expanded age indication—ie, in women and men aged 27 to 45 years—for the prevention of certain cancers and diseases caused by the 9 HPV types covered by the vaccine. The FDA has granted Priority Review to this … (leggi tutto)