Biologics

Subcutaneous Skyrizi OK’d for At-Home Induction in Crohn’s

FDA has approved AbbVie’s subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD). “Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then continue using an OBI once every eight weeks throughout the course of maintenance treatment,” a company release says.

The approval was based on positive results from the Phase 3 AFFIRM trial evaluating the efficacy and safety of SC Skyrizi versus placebo in patients with moderately to severely active CD, AbbVie says. “Skyrizi achieved superiority of the co-primary endpoints of clinical remission and endoscopic response at week 12,” it adds. “Although the study enrolled a primarily treatment-refractory population, these Phase 3 results were particularly strong within patients without prior advanced therapy failure (advanced therapy-naïve).” At Week 12, 74% of advanced therapy-naïve patients were in clinical remission compared with 27% for those on placebo.

Quality Procedures, Investigations Top FDA Drug Citations

Failures to establish or follow written quality procedures and inadequate investigations of manufacturing problems were the most frequently cited deficiencies in FDA drug-quality inspections conducted during 2026, according to an FDA Webview analysis of agency inspection data. FDA cited deficiencies involving written quality-unit procedures in 74 inspections, representing

Risk Management, Corrective Actions Lead Device Inspection Findings

Risk-management deficiencies and inadequate corrective action procedures were the most frequently recorded problems in FDA medical device inspections conducted under the agency's new Quality Management System Regulation (QMSR), according to an FDA Webview analysis of 2026 inspection data. FDA cited failures to document risk-management processes associated

FDA Posts 172 Additional Inspection Records

FDA has begun releasing large batches of Form FDA-483 inspection reports under its expanded transparency initiative (see earlier story), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records

Brand, Generic Drug Groups Seek Changes to Approval Pathways Guide

Brand-name and generic drug manufacturers are urging FDA to revise its proposed guidance (see earlier story) on determining whether sponsors should submit an ANDAor a 505(b)(2) application, with the two industry groups emphasizing different concerns about the agency's interpretation of the approval pathways. In separate

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Quality Procedures, Investigations Top FDA Drug Citations

Risk Management, Corrective Actions Lead Device Inspection Findings

FDA Posts 172 Additional Inspection Records

Brand, Generic Drug Groups Seek Changes to Approval Pathways Guide