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.
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.
AUA, SUFU publish 2024 guideline for idiopathic overactive bladder
April 25th 2024“This brand new guideline offers options for all patients with OAB with a focus on shared decision-making between patients with OAB and clinicians, as well as a personalized, tailored approach to care,” said Cameron and Smith.
Enzalutamide granted approval in EU for nmHSPC
April 24th 2024The approval is supported by data from the phase 3 EMBARK trial, which demonstrated that enzalutamide with or without leuprolide prolonged metastasis-free survival compared with leuprolide alone in patients with high-risk biochemically recurrent nmHSPC.