April 28, 2026

FDA Clears Self-Administered Lupus Therapy

Once-weekly autoinjector approval was based on Phase 3 data, with safety consistent with intravenous administration.

Conexiant

April 28, 2026

FDA Clears Breztri for Asthma Use

Single-inhaler triple therapy improved lung function vs dual therapy in phase 3 trials and showed rapid onset without new safety signals.

Conexiant

April 24, 2026

Dupilumab Gains Pediatric CSU Approval

Targets type 2 inflammation in a population with limited treatment options

Conexiant

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The agency outlined early regulatory actions supporting nonanimal methods, including draft guidance, artificial intelligence tools, and expanded use of human-relevant data models.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 16, 2026

When ‘Family Planning’ Shifts Meaning

A program built on prevention now tilts toward population goals, testing the balance between public health and personal choice.

KFF Health News

April 16, 2026

When ‘Family Planning’ Shifts Meaning

A program built on prevention now tilts toward population goals, testing the balance between public health and personal choice.

KFF Health News