The FDA approves remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor label via the Phase III RemIND trial.
News|Videos|June 25, 2026
Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56
This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.
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In this episode of PharmTech’s Pharma Fundamentals, Susan Schniepp, distinguished fellow with Nelson Labs and a member of PharmTech's editorial advisory board, and Amnon Eylath, president and founder of Broad Spectrum GXP, discuss biologics development, the quality system, and the Parenteral Drug Association's (PDA) revision to Technical Report No. 56 (TR56),1 which Eylath is a co-author on.
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