On preclinical science, Gardiner welcomes FDA’s growing flexibility, including its plausible mechanism framework. Patient-derived cell lines, humanized transgenic mice, and targeted large-animal ...
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up ...
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, ...
In the October 2026 episode of PharmTech’s Ask the Expert video series, Jane Zhang, co-founder and co-CEO of ETCH Sourcing, joins Susan J. Schniepp, distinguished fellow at Nelson Labs, to answer the ...
Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic ...
Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and ...
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating ...
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice. Ahead ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results