Monthly Prescribing Reference

Rinatabart Sesutecan Designated Breakthrough Therapy for Advanced Endometrial Cancer

Findings showed in the rinatabart sesutecan 100mg/m 2 cohort, the confirmed ORR was 50%, with 2 patients achieving complete response. The Food and Drug Administration (FDA) has granted Breakthrough ...
Monthly Prescribing Reference

Methylone Designated Breakthrough Therapy for PTSD

Treatment with TSND-201 was associated with statistically significant improvement in PTSD symptoms. The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TSND-201 ...
MedTech Dive

FDA breakthrough program starts FY2026 at steady pace

Orthopedics was the most active area over the second half of 2025, with the FDA issuing 13 breakthrough designations to ...
The American Journal of Managed Care

Pemvidutide for MASH Earns FDA Breakthrough Therapy Designation

This article originally appeared on HCPLive®. The FDA has granted breakthrough therapy designation (BTD) for pemvidutide for the treatment of metabolic dysfunction–associated steatohepatitis (MASH). 1 ...
Seeking Alpha

Cidara Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for CD388 in Seasonal Influenza Prevention

SAN DIEGO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (CDTX), a biotechnology company using its proprietary Cloudbreak ® platform to develop drug-Fc conjugate (DFC) therapeutics, ...
STAT

For AI-based ‘breakthrough’ medical devices, Medicare coverage may become easier

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...