OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, ...

FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up ...

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 ...

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 ...

FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic ...

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 ...

Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.

Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.

The scope covers prescription drugs and drug-led, drug-device combination products where the Center for Drug Evaluation and ...

Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice. Ahead ...

Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and ...