FDA News

Insulet enhances the Omnipod® 5 system with new glucose targets and algorithms, improving insulin delivery for diabetes management.

Your daily dose of the clinical news you may have missed.

New safety and biomarker results from MK-2214 and MK-1167 advance Merck’s dual approach to Alzheimer therapy.

Former CBER chief calls claims "misrepresentation." ID experts Offit and Osterholm criticize timing ahead of CDC advisory committee meeting next week.

Otsuka seeks FDA approval for centanafadine, a novel ADHD treatment showing significant efficacy and safety in pivotal trials for all age groups.

Novartis's Itvisma gains FDA approval as the first intrathecal gene therapy for spinal muscular atrophy, promising improved motor function and independence.

Deep TMS becomes first FDA-cleared brain stimulation therapy for adolescents with treatment-resistant depression and is now available for ages 15-86 for MDD treatment.

Submission of the sNDA suggests a potential FDA decision on the dextromethorphan-bupropion combination sometime during the first quarter of 2026.

ACAAI 2025: Phase 3 results show dupilumab significantly reduced sinus opacification, nasal congestion, and polyp size in patients with AFRS.

Your daily dose of the clinical news you may have missed.