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 ...
Healio

FDA grants breakthrough designation to ianalumab for Sjögren’s disease

Please provide your email address to receive an email when new articles are posted on . Ianalumab has received the FDA’s breakthrough therapy designation for Sjögren’s disease. Novartis plans to ...
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, ...
Healio

Raludotatug deruxtecan gains FDA breakthrough therapy designation for gynecologic cancers

Please provide your email address to receive an email when new articles are posted on . Raludotatug deruxtecan has received breakthrough therapy designation for treatment of certain adults with ...
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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 ...