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

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships ...

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be ...

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 ...

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 ...

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

On October 14, 2026, the FDA expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with high-grad ...

AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup. This week on PharmTech.com, the FDA moved to shorten first-in-human ...

Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data. Boyang Wang, founder of Immortal ...

As GLP-1 therapies evolve from single-agonist peptides toward dual and triple agonists, formulation and CMC teams face a more ...