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October 17, 2024
Article
Following the approval of sodium oxybate for cataplexy in adults with cataplexy, the FDA approves this indication for the pediatric population.
The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.
October 15, 2024
The Accure Laser System is indicated for long term treatment of patients known to have mild to severe inflammatory acne vulgaris.
Podcast
Brian Hansen, president of CGM at Ascensia Diabetes Care, joins the podcast to discuss the FDA clearance of the Eversense 365 CGM.
October 14, 2024
Antonio Anzueto, MD, discusses how dupilumab fits into treatment algorithms for patients with uncontrolled COPD.
Stephanie Christenson, MD, discusses the impact of recent regulatory approvals and pipeline movement for chronic obstructive pulmonary disease.
The ustekinumab biosimilar will be available in early 2025, with indications to treat psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
October 11, 2024
The sNDA submission to the FDA included a Priority Review Voucher, which commits the regulatory agency to an accelerated review timeline.
October 10, 2024
The designation was granted to Mirum Pharmaceuticals based on a positive interim analysis of the phase 2b VANTAGE study of volixibat.
October 08, 2024
The FDA's decision to issue a CRL was announced on October 08, 2024 and cites issues with the timing of the facility inspection.