FDA Roundup of the Week: October 20


Catch up on all the past week's action in US Food and Drug Administration rulings and decisions.

FDA Approves Golimumab for 2 New Indications

REVOLVE Trial for Crohn's Disease Canceled

FDA Advisory Committee Recommends Semaglutide

Ingrezza Continues to Expand in TD Market

After a busy series of decisions, the US Food and Drug Administration (FDA) had a slow week. No New Drug Applications met the market outside of oncology pharmaceuticals, and some decisions showed the administration's more critical and deliberate standard of regulation. Catch up on all the action with the FDA Roundup of the Week:The FDA approved the rheumatoid arthritis therapy for supplemental indications including psoriatic arthritis in adults with active ankylosing spondylitis. It is the only fully-human anti-tumor necrosis factor alpha therapy administered with a 30-minute infusion.Earlier this month, the administration’s Data Monitoring Committee recommended Celgene discontinue its REVOLVE trial and its extension (SUSTAIN), testing oral compound GED-0301 (mongersen) for CD. Mongersen is a Smad7 protein-decreasing oligonucleotide that was considered for CD therapy due to its impact on TGF beta-1 signaling.The once-weekly injection therapy for improved glycemic control in adults with type 2 diabetes was given unanimous 16-0 backing by the committee. The Novo Nordisk product is now expected to gain FDA approval and improve on liraglutide (Victoza).The first-ever approved drug for tardive dyskinesia has been granted a supplemental dosing indication. Valbenazine (Ingrezza) capsules are now approved for 80 mg, once-daily therapy paired with psychiatric medications.

Recent Videos
Getting Black Men Involved in Their Health Care, Clinical Research
Patient Involvement in Advanced HF Treatment, with Ashley Malliett, DMSc, MPAS, PA-C
Aaron Henry, PA-C, MSHS: Regaining Black Male Patient Trust in the Doctor's Office
What Should the American Academy of Physician Associates Focus on in 2025?
© 2024 MJH Life Sciences

All rights reserved.