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Top 5 Healthcare Headlines for June 30-July 6, 2025:
Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema
The FDA approved sebetralstat (Ekterly) on July 7, 2025, as the first oral, on-demand treatment for hereditary angioedema attacks in patients aged 12 and older, backed by phase 3 KONFIDENT trial data.
Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial
Rilparencel significantly slowed kidney function decline in CKD patients with diabetes in the REGEN-007 trial, showing dose-responsive eGFR slope improvements after two injections per kidney.
J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse
J&J filed a supplemental NDA for lumateperone after phase 3 data showed a 63% reduction in schizophrenia relapse risk compared to placebo.
FDA Publishes CRLs for Past Drug, Biological Product Applications
The FDA publicly released over 200 Complete Response Letters from 2020–2024 to increase regulatory transparency and help accelerate future drug approvals.
FDA Grants TSND-201 Breakthrough Therapy Designation for PTSD
TSND-201 (methylone) received Breakthrough Therapy designation for PTSD on July 10, 2025, offering a potential rapid-acting alternative to SSRIs, which can take up to 12 weeks for full effect.
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