The US Food and Drug Administration today approved Merck’s Gardasil 9, a vaccine that offers protection against 5 more types of Human Papillomavirus (HPV) than original Gardasil. In addition to preventing cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18 (those prevented by the older version of Gardasil) Gardasil 9 also prevents those cancers caused by HPV strains 31, 33, 45, 52, and 58.
Obizur (Antihemophilic Factor [Recombinant], Porcine Sequence) has been approved to treat acquired hemophilia A (acquired Factor VIII deficiency), a rare, non-inherited form of hemophilia.
The US Food and Drug Administration (FDA) approved Genzyme’s application to include new information about its multiple sclerosis drug teriflunomide (Aubagio) on its label. The new labeling content is efficacy and safety data from two Phase III trials of the drug.