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 ...
AstraZeneca and insitro announced on Oct. 15, 2026, a strategic drug discovery collaboration and licensing agreement that ...
In the latest installment of the PharmTech AI Pulse Check video series, Associate Editorial Director Christopher Cole is ...
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors ...
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