Merck & Co. Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Merck & Co.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, June 20, 2018 to Tuesday, June 29, 2018.
FDA Grants Priority Review to Merck & Co.’s sBLA for New Use for HPV Vaccine Gardasil
The US Food and Drug Administration (FDA) has accepted Merck & Co.’s new supplemental biologics license application (sBLA) for Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), a 9-valent HPV vaccine, regarding a new indication in age.
The application is seeking approval for an expanded age indication for Gardasil 9 for use in women and men ages 27 to 45 for preventing certain cancers and diseases caused by the nine HPV types covered by the vaccine. The FDA has granted priority review to this sBLA and has set a Prescription Drug User Fee Act, or target action, date of October 6, 2018.
Source: Merck & Co.