FDA & Government News

July 02, 2026

FDA Expands Gene Therapy for Younger Patients

Exagamglogene autotemcel is now indicated for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.

Conexiant

July 01, 2026

FDA Approves Treg Cell Therapy

A randomized clinical trial found higher chronic GVHD-free survival and lower rates of serious chronic GVHD compared with standard transplantation in adults with blood cancers.

Conexiant

July 01, 2026

NEJM Retracts Avacopan Vasculitis Study

"The primary end-point assessments in nine patients were readjudicated after database lock and trial unblinding"

Conexiant

June 26, 2026

FDA Approves New First-Line TNBC Regimen

Phase 3 results showed longer progression-free survival with pembrolizumab plus sacituzumab govitecan-hziy than with pembrolizumab plus chemotherapy in previously untreated PD-L1-positive advanced triple-negative breast cancer.

Conexiant

June 23, 2026

HHS Announces Department-Wide Clinical Trial Initiative

Agency-wide effort targets US clinical trial timelines, enrollment, and regulatory barriers.

Conexiant

Daily News

Stay up to date with the latest clinical headlines and other information tailored to your specialty.

June 11, 2026

FDA Clears Home Urine Collection Kit for STI Testing

The clearance enables a validated mail-in workflow for self-collected urine specimens processed on Roche cobas systems.

Conexiant

June 08, 2026

FDA Expands Marstacimab Indication in Hemophilia A and B

Phase 3 BASIS and BASIS KIDS data supported the expanded indication across pediatric and inhibitor-pretreated populations.

Conexiant

June 04, 2026

HHS Seeks Broader Access to Health Data

"We can’t do anything our agreements don’t allow us to do"

Kff Health News

May 20, 2026

FDA Approves Expanded Liquid Biopsy Panel

Updated liquid biopsy combines genomic and epigenomic profiling for companion diagnostic use across multiple tumor types.

Conexiant

May 15, 2026

Why FDA Said No to a Melanoma Drug

Questions over trial design and political pressure shadowed the rejection of Replimune’s RP1 treatment.

Kff Health News

Diet-Dementia Link Varies by Biomarkers

FDA & Government News

FDA Expands Gene Therapy for Younger Patients

FDA Approves Treg Cell Therapy

NEJM Retracts Avacopan Vasculitis Study

FDA Approves New First-Line TNBC Regimen

HHS Announces Department-Wide Clinical Trial Initiative

Daily News

FDA Clears Home Urine Collection Kit for STI Testing

FDA Expands Marstacimab Indication in Hemophilia A and B

HHS Seeks Broader Access to Health Data

FDA Approves Expanded Liquid Biopsy Panel

Why FDA Said No to a Melanoma Drug

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