In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...

For more than a decade, external and historical controls have occupied a complicated middle ground in US Food and Drug ...

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...

Rare disease is a major – and growing – area of clinical research and drug development. Of the FDA’s 46 novel drug approvals ...

At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

Intuitive Surgical, Edwards and Electromed tap GenAI tailwinds as AI healthcare spending surges, despite industry under ...

The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming ...

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026Company ...

Non-cash charges in Q4 2025 included a $12.6 million warrant expense and $11.9 million in interest related to the accounting treatment of the Royalty Pharma arrangement.