News & Analysis

Curated news and analysis on clinical trials, drug approvals, and medical research.

FDA Approves First-in-Class Oral Antibiotic Nuzolvence for Gonorrhea

The U.S. FDA approved Nuzolvence (zoliflodacin), a single-dose oral treatment for uncomplicated urogenital gonorrhea, based on a non-inferiority Phase 3 trial. Thailand also authorized the drug under the brand Nuzolvance, expanding access in low- and middle-income countries.

NEXT BIOMEDICAL and NexEos Bio Reach FDA Milestones

NEXT BIOMEDICAL completed an FDA pre-submission review for Nexsphere-F under the TAP program. NexEos Bio received IND clearance to begin a Phase II/III trial of NTX-1024 for vernal keratoconjunctivitis, supported by positive early clinical data.

Experts Warn Hepatitis B Treatment Too Complex; Philippines Faces High Burden

In the Philippines, an estimated 7.3 million adults live with chronic hepatitis B, far above regional averages. Experts warn that complex treatment guidelines may hinder front-line clinicians from initiating care, while Thailand’s success with vaccination shows a path to elimination. Expanding screening and simplifying treatment are critical steps.

Innovative Funding and Digital Twins Drive Rare Disease Drug Development

New investment models and digital twin technologies are bridging gaps in rare disease drug development, where traditional funding and trial designs fall short. Patient-led funding and family offices provide capital, while regulators accept digital evidence to accelerate therapies for the more than 7,000 rare diseases with few approved treatments.

Study: Beyfortus Reduces RSV Hospitalizations Over Two Seasons Amid FDA Warning

A real-world study in Galicia showed nirsevimab reduced RSV-related hospitalizations by 85.9% in the first season and 55.3% in the second. The RSV prevention market is expanding to cover high-risk children, with Beyfortus the only antibody approved for second-season use. The FDA has cited Sanofi for misleading promotional claims about the product.

Newer
Sorted by date
Older
Showing 20 articles per page