AstraZeneca and insitro announced on Oct. 15, 2026, a strategic drug discovery collaboration and licensing agreement that ...
As GLP-1 therapies evolve from single-agonist peptides toward dual and triple agonists, formulation and CMC teams face a more ...
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 ...
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...
In the latest installment of the PharmTech AI Pulse Check video series, Associate Editorial Director Christopher Cole is ...
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating ...
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 ...
The FDA's expanding embrace of new approach methodologies (NAMs) is forcing pharmaceutical manufacturing and quality teams to rethink how preclinical and CMC data will be generated, validated, and ...
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