The failure of what was once considered a potential blockbuster therapy for a tough-to-treat rare disease is forcing Ultragenyx to examine its expenses.

The company is hoping for an affirmative answer on its application after dealing with unusual regulatory setbacks.

Teva's positive data in celiac disease could open a new therapeutic franchise for the company.

A major new initiative aims to apply artificial intelligence to fundamental biology research.

Wall Street analysts believe a more cautious approach to manufacturing and enrollment could help avoid future safety hazards in autoimmune cell therapy.

The new models aim to support clinicians with AI-driven insights in healthcare settings.

The TEMPO pilot program allows digital health companies to release certain AI products without full marketing authorization.

Private Medicaid-focused deals may result in drugmakers agreeing to lower prices in Medicaid but avoiding cuts in Medicare.

The federal agency is backing companies developing personalized RNA-based treatments.

The French drugmaker remains independent while other biotech companies are being bought up, raising questions among observers.

A new Commonwealth Fund report suggests naloxone and harm reduction measures may be curbing overdose deaths.

The startup is focusing on basic but overlooked challenges at the intersection of AI and biology.

The department reversed its position in a lawsuit regarding community-based care for people with disabilities.

Commercial challenge of CAR-T therapy involves making thousands of patient-specific manufacturing runs behave reliably, with in vivo techniques as a potential s

Professional organizations issued guidance on flu, COVID, and RSV vaccines for the upcoming season.

A STAT columnist highlights unexpected progress by the FDA in cracking down on unproven stem cell marketing.

Anthony Fauci is working on a book as he continues to weigh in on drug pricing and vaccine skepticism.

The two companies resolved their intellectual property disagreement.