Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Celebrex Likely To Get Label Change Saying CV Risk Is Comparable To Ibuprofen, Naproxen
Despite concerns about difference in dosages and study discontinuation rates, US FDA advisory committee concludes that Pfizer's study demonstrated similar CV risk among the three NSAIDs.
Lilly's Baricitinib Wins US FDA Panel Thumbs Up For One Of Two Doses
Despite concerns about small size of safety database, Arthritis Advisory Committee endorses 2 mg dose; panel recommends against approval of 4 mg dose due to stronger thrombosis signal in clinical trials, brushing back Lilly's attempt to position the higher dose as having a positive benefit-risk profile in patients with more refractory disease.
Epidiolex Enjoys Mellow Advisory Cmte. Meeting
GW Pharmaceuticals’ cannabis-derived epilepsy drug gets unanimous panel endorsement, affirming US FDA's belief that there are no obstacles to approval.