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.
The US Food and Drug Administration (FDA) has approved the use of an experimental drug to treat patients who have Ebola Virus Disease.
Trulicity (dulaglutide) is a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Stendra (avanafil) is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.
The FDA has approved Baxter’s Rixubis [Coagulation Factor IX (Recombinant)], an intravenous prophylactic treatment intended to control and prevent bleeding episodes and assist with perioperative management for children 12 years and younger with hemophilia B.
Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) is a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
GeNeuro, a Swiss company specializing in promising therapies for neurological disorders, recently announced positive results from a Phase IIa study of a new drug for multiple sclerosis (MS).