Drug Approval | January 14, 2026
Camurus’ Oclaiz NDA resubmission accepted by FDA
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
The approval introduces a needle-free alternative to injectable GLP-1 therapies
Elanco expects Befrena to launch in the US in the first half of 2026
The study met its primary endpoint with flying colors
TMS offers new hope to patients suffering from stroke, migraine, neuropathic pain, depression, and other disorders
Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
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