April 23, 2026

FDA Grants Accelerated Approval for OTOF Gene Therapy

A one-time intracochlear gene therapy improved hearing outcomes in patients with OTOF-related sensorineural hearing loss in the phase 1/2 CHORD trial.

Conexiant

April 22, 2026

Tzield Approval Expands to Younger Patients

First disease-modifying option available for children as young as 1 year with stage 2 type 1 diabetes

Conexiant

April 21, 2026

Two-Drug HIV Regimen Gains FDA Approval

Phase 3 trials showed noninferior viral suppression vs standard three-drug therapy with similar safety outcomes

Conexiant

April 20, 2026

FDA Reshapes Drug Testing Approach

The agency outlined early regulatory actions supporting nonanimal methods, including draft guidance, artificial intelligence tools, and expanded use of human-relevant data models.

Conexiant

April 16, 2026

FDA Signals New Testosterone Pathway

Agency invites sponsors to pursue low libido indication

Conexiant

April 14, 2026

FDA Approval Targets Rare Kidney Disease

Phase 3 data showed greater proteinuria reduction vs irbesartan, with similar tolerability and a 1.1 mL/min/1.73 m² difference in estimated glomerular filtration rate at 108 weeks.

Conexiant

April 13, 2026

FDA Flags Missing Trial Results

Federal outreach seeks to improve compliance with ClinicalTrials.gov reporting requirements and make more complete clinical trial information publicly available

Conexiant

April 10, 2026

Where Oversight, Compliance, and Risk Intersect

Cases spanning fraud, regulation, and criminal law illustrate how gaps and uncertainty can influence outcomes in healthcare settings

Conexiant

April 09, 2026

Marriage as a Marker of Cancer Risk?

Never-married adults show markedly higher cancer incidence. A large population study asks why marital status remains a footnote in risk frameworks.

Conexiant

April 08, 2026

FDA Clears At-Home HPV Screening Tool

Self-collection approach aims to expand screening access

Conexiant