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 grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic ...
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 approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up ...
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice. Ahead ...
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, ...
The scope covers prescription drugs and drug-led, drug-device combination products where the Center for Drug Evaluation and ...
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...
Germany is the European Union’s (EU) largest pharmaceutical market by revenue and has the highest medical biotechnology ...
AstraZeneca and insitro announced on Oct. 15, 2026, a strategic drug discovery collaboration and licensing agreement that ...
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating ...
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