HCPLive 5 Stories in Under 5: Week of 01/04

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 3-10, 2025:

Here are one-sentence, clinician-focused summaries with titles restated and no statistics included:

1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP Therapy

The FDA approved caplacizumab for adolescents with aTTP, making it the first therapy specifically indicated for pediatric patients with this condition.

2. Pemvidutide Gets Breakthrough Therapy Designation for MASH

The FDA granted Breakthrough Therapy Designation to pemvidutide for MASH, supporting its accelerated development based on promising mid-stage clinical data and alignment on a registrational phase 3 program.

3. FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy

The FDA granted Priority Review to the BLA for atacicept, advancing a potential new biologic therapy for adults with IgA nephropathy.

4. FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

The FDA approved a higher-dose presentation of Fibryga, expanding dosing flexibility for fibrinogen replacement in patients with acquired fibrinogen deficiency.

5. FDA Accepts for Priority Review sBLA for Teplizumab for Children With Stage 2 T1D

The FDA accepted a Priority Review sBLA for teplizumab to expand its use to younger children in order to delay progression to clinical type 1 diabetes.