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FDA's SrLC Database: A Compliance Tool Too Few Teams Are Using
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ProBioGen COO Appointment Signals Biologics Ops Shift

Pharma Now Editorial Team

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FDA's SrLC Database: A Compliance Tool Too Few Teams Are Using

FDA's SrLC database tracks NDA and BLA safety labeling changes since 2016 -- a postmarket surveillance tool regulatory teams should be actively monitoring.

Pharma Now Editorial Team

Pharma Now

ProBioGen COO Appointment Signals Biologics Ops Shift

ProBioGen names Dr. Simon Johannes Bulling COO, signalling integrated operational leadership across biologics drug substance and drug product manufacturing.

Pharma Now Editorial Team

Pharma Now

FDA PreCheck Pilot Opens a New Lane for Domestic Facility Development

FDA opens PreCheck Pilot applications February 1, 2026, embedding regulatory review into new domestic facility development before any product submission.

Pharma Now Editorial Team

Pharma Now

Fenebrutinib Clears Phase III Bar, NDA Filing Now in Sight for RMS and PPMS

Roche's fenebrutinib cut relapse rates by up to 58.5% vs teriflunomide in Phase III, with a combined RMS and PPMS regulatory submission now confirmed.

Pharma Now Editorial Team

Pharma Now