FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
Summary
The FDA has released new draft guidance providing a standardized “roadmap” for using next-generation sequencing to evaluate off-target risks, aiming to safely accelerate the development of transformative gene therapies for rare and incurable diseases.
5 FDA decisions to watch in the second quarter of 2026
Summary
The second quarter of 2026 presents a critical test for the FDA’s regulatory flexibility as it weighs high-stakes decisions on breakthrough therapies for melanoma, obesity, breast cancer, hypertriglyceridemia, and Alzheimer’s agitation.
Analysis: Why the research money isn’t flowing from NSF and NIH
Summary
The White House is utilizing routine administrative processes to delay and potentially restrict the release of billions in congressionally approved funding for the NIH and NSF, sparking fears of significant research budget cuts that favor administration priorities over legislative mandates.
In industry’s latest OTC pivot, Daiichi Sankyo lines up $1.5B consumer health unit sale to beverage giant Suntory
Summary
Daiichi Sankyo is selling its consumer health unit to Suntory for $1.55 billion to pivot its full focus toward its rapidly growing oncology portfolio and ambitious antibody-drug conjugate (ADC) expansion.
Ideaya sees clear path to FDA as Servier-partnered eye cancer drug hits goal in phase 2/3 trial
Summary
Ideaya Biosciences and Servier’s darovasertib combination significantly doubled progression-free survival in metastatic uveal melanoma patients, clearing a path for a targeted FDA accelerated approval filing later this year.
