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 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The agency outlined early regulatory actions supporting nonanimal methods, including draft guidance, artificial intelligence tools, and expanded use of human-relevant data models.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 02, 2026

CDC Lists Dozens of Infectious Disease Tests as Unavailable

More than two dozen assays paused or discontinued, with alternative testing options noted

Conexiant

April 02, 2026

USDA Alerts on Lead in Walmart Chicken Nuggets

Detected lead could be up to five times FDA’s interim reference level for children

Conexiant

March 31, 2026

FDA Monthly Preview: Key April Decisions to Watch

Several high-stakes FDA decisions across multiple specialties are expected this month.

Conexiant

March 30, 2026

FDA Updates SMA Treatment Dosing

A higher-dose nusinersen regimen for spinal muscular atrophy demonstrated statistically significant motor function improvement in treatment-naïve infants in the DEVOTE trial with a safety profile consistent with prior dosing.

Conexiant

March 23, 2026

Fibromyalgia Drugs Tested for Value

Investigators compare common fibromyalgia therapies.

Conexiant

March 17, 2026

Obesity Medications Get New Guidance

Panel outlines pharmacotherapy roles across obesity complications and long-term weight management.

Conexiant

March 10, 2026

FDA Approves Therapy for Cerebral Folate Deficiency

Decision addresses a rare neurologic disorder linked to folate transport impairment.

Conexiant

March 02, 2026

FDA Okays Weekly Option in Achondroplasia

Navepegritide is described as the first therapy to deliver continuous C-type natriuretic peptide exposure over a weekly dosing interval in eligible pediatric patients.

Conexiant