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regulatory
Pharma
FDA official chastises Aurinia med in now-deleted LinkedIn post
In a now-deleted LinkedIn post, the CDER's chief claimed that Lupkynis carries “significant toxicity” despite failing to show direct clinical benefit.
Fraiser Kansteiner
Sep 30, 2025 10:15am
Regulatory tracker: J&J's Tremfya picks up 2 pediatric FDA nods
Sep 29, 2025 2:30pm
Fierce Biotech
Lilly's oral GLP-1 charts 10.5% weight loss in diabetic patients
Aug 26, 2025 6:45am
Argenx pursues Vyvgart nod in seronegative myasthenia gravis
Aug 25, 2025 11:38am
FDA debuts new program to ease US manufacturing plant setup
Aug 7, 2025 3:16pm
Vertex narrows development plan for non-opioid pain med Journavx
Aug 5, 2025 10:55am
