India, Oct. 29 -- The FDA's November calendar has more than a dozen PDUFA dates on the horizon, setting the stage for an eventful month in the regulatory landscape.
Before turning to what lies ahead, let's look back at some of the regulatory developments that made headlines in October.
The month saw several notable milestones, including approvals that marked important firsts, from a growth-accommodating heart valve for children to new treatment options for bladder cancer and chronic hepatitis B.
On October 1, the FDA approved Edwards Lifesciences' Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve, intended for pediatric patients with congenital pulmonary valve disease. It is the first heart valve designed to be ex...