HCPLive 5 Stories in Under 5: Week of 01/11

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for January 11-17, 2025:

1. FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

The FDA cleared Medtronic’s MiniMed Go Smart MDI app for pediatric and adult patients with type 1 or type 2 diabetes, enabling integrated smart pen and sensor–based decision support to improve insulin dosing with multiple daily injections.

2. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The FDA approved ProlivRx as the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded adequately to antidepressant treatment.

3. FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

The FDA requested removal of suicidal ideation and behavior warnings from GLP-1 receptor agonist labels after determining there is no increased risk associated with these therapies.

4. FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

The FDA extended the review timeline for sparsentan’s supplemental NDA in focal segmental glomerulosclerosis, delaying the PDUFA decision without requesting additional safety or manufacturing data.

5. FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

The FDA approved new, more portable packaging for over-the-counter Narcan nasal spray to improve usability, reduce stigma, and increase the likelihood that naloxone is carried and available during overdose emergencies.