The PDUFA target action date is in the fourth quarter of 2026.
|Articles|June 24, 2004
Organizations work to streamline approval of prostate cancer drugs
Four leading prostate cancer advocacy groups are working in cooperation with the FDA to streamline the approval process of critical prostate cancer treatments by changing clinical trial endpoints, without compromising safety.
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The approval is supported by data from the phase 3 LITESPARK-011 trial.
Pearls & Perspectives: Expanding Sexual Health Conversations Through Digital Media, With Wendy Brant
Amy Pearlman, MD, and Wendy Brant discuss building a digital audience, navigating sexual health content online, and the role of communication in relationships.
Positive safety and efficacy data from 4 clinical studies supported the CE marking.
Sandip Prasad, MD, discusses patient selection for chemoablation in recurrent LG-IR-NMIBC and considerations when counseling patients about a nonsurgical approach.
In a head-to-head RCT, Rezūm produced a 4.6-point greater IPSS improvement than combination pharmacotherapy at 1 year, according to Jean-Nicolas Cornu, MD, PhD, FEBU.
The AACU and the WOCN Society urge CMS to protect access to individualized catheter and ostomy supplies as competitive bidding begins in 2028.
Better detection has changed prostate cancer care. Patients choosing radical treatment still need better protection from the disease returning.
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