The HCPFive: Top News for Healthcare Providers from the Week of 12/28
January 4, 20264m 34s
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Show Notes
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 December 28-January 3, 2025:
1. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care
The FDA granted 510(k) clearance to StimLabs’ Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation.
2. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion
The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting.
3. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism
The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials.
4. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD
The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application.
5. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation
The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer’s disease.
Interested in a more traditional, text rundown? Check out the HCPFive!
Top 5 Healthcare Headlines for December 28-January 3, 2025:
1. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care
The FDA granted 510(k) clearance to StimLabs’ Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation.
2. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion
The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting.
3. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism
The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials.
4. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD
The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application.
5. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation
The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer’s disease.