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 ...

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

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, ...

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

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Germany is the European Union’s (EU) largest pharmaceutical market by revenue and has the highest medical biotechnology ...

Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human ...

Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create. A newly launched research initiative is ...

Silence, and Lilly-METiS deals show how ADCs, siRNA, and lipid nanoparticles reshape demands on CMC and manufacturing teams.