Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs).
New research questions the effectiveness of the FDA's accelerated drug approval program after finding that most cancer drugs remain unproven five years later.
Casgevy, a groundbreaking treatment approved to treat sickle cell disease in December, has now been approved to treat another inherited blood disorder.
As the year draws to a close, it's time to assess the current status regarding the approval of novel drugs, also referred to as new molecular entities. As of this writing, 55 novel drugs have been greenlighted by the U.