Clean, humanized data and data systems are the crucial fuel for engines driving new AI capabilities and uses across the ...

When looking for a place to grow a life sciences business over the long term, sometimes the biggest location isn't ...

The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including ...

Life Biosciences' Jerry McLaughlin and Forge Biologics' John Maslowski explain the importance of transparency and collaboration when encountering manufacturing speed bumps.

"A version of this article was published first on Hyman, Phelps & McNamara’s FDA Law Blog. It is republished here with permission." In November, President-Elect Trump announced his pick of Robert ...

Dr. Tal Zaks is back, along with Advancing RNA's Anna Rose Welch, for part 2 of "Story Time With Tal." On this week's episode, we turn from his time navigating medical affairs as CMO at Moderna during ...

Local affiliates face significant time demands, often with very limited resources. These demands are perhaps most keenly felt in pharmacovigilance (PV). In many markets, requirements can include ...

Biopharma guru Allan Shaw speculates on the risks and benefits that the incoming Trump administration could bring to the industry.

Recent proposed bills have targeted patents on branded drugs that may be asserted against potential generic or biosimilar manufacturers. The stated motive behind this trend is to make the lower-priced ...

Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK ...

The FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program — it’s a mouthful. And, if we don’t act now, it will sunset at the end of the year. I care. Why should you? Rare diseases impact ...

Data drives decision-making at Aulos Bioscience. It's also driven the career trajectory of its CEO. On this week's episode of the Business of Biotech podcast, we get an introspective walk through Aron ...