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November 07, 2025
Video
Julie Khlevner, MD, AGAF, highlights that FDA approval of linaclotide provides the first pharmacologic therapy for pediatric IBS-C.
November 06, 2025
Article
At NASPGHAN 2025, investigators presented 52-week safety data from an ongoing phase 3 trial of linaclotide, the first approved treatment for patients aged 7 and older with IBS-C.
November 05, 2025
The decision makes linaclotide (Linzess) capsules the first FDA-approved treatment for pediatric patients 7 years and older with irritable bowel syndrome with constipation.
Catch up on the groundbreaking FDA approvals, key trial updates, and more news from the last month.
ABBV-CLS-628, an anti–PAPP-A monoclonal antibody, earns Orphan Drug Designation, advancing through phase 2 testing for ADPKD.
Stay up to date with the groundbreaking FDA decisions, critical trial updates, and more news from the last month.
November 04, 2025
Based on results from the THRIVE and THRIVE-2 phase 3 studies, this Biologics License Application includes a request for Priority Review.
Catch up with groundbreaking FDA decisions, exciting new GLP-1 news, and more.
November 03, 2025
The FDA has approved Kygevvi (doxycitine and doxribtimine), the first therapy to improve functional outcomes and survival in thymidine kinase 2 deficiency.
Following a Type A meeting with the FDA, the ophthalmic formulation of bevacizumab is back on track towards a potential US approval.
