One year following the approval of the gemcitabine intravesical system, Joseph Jacob, MD, reflects on the expanding treatment landscape in BCG-unresponsive NMIBC.
|Articles|December 6, 2007
FDA accepts new drug application for ED topical cream
FDA has accepted a new drug application for a topically applied alprostadil cream for the treatment of erectile dysfunction, according to NexMed, Inc., the drug’s developer.
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FDA has accepted a new drug application for a topically applied alprostadil cream for the treatment of erectile dysfunction, according to NexMed, Inc., the drug’s developer.
The acceptance for review is an indication that FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of 8 months, should the agency not require any additional studies or information, the company said.
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A limited market release of SpaceOAR Flex is expected to begin in the US later this year.
The PDUFA target action date is in the fourth quarter of 2026.
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.
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