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December 23, 2024
Article
The FDA's approval marks the second generic approval referencing a GLP-1 receptor agonist in as many months for the agency.
Concizumab marks the first subcutaneous injection treatment for hemophilia A or B with inhibitors, demonstrating an 86% reduction in bleeds in pivotal trial data.
December 20, 2024
Tirzepatide's approval marks the first and only prescription medicine available for adults with moderate-to-severe obstructive sleep apnea and obesity.
The FDA's decision not to approve sotagliflozin as an adjunct in T1D and CKD comes less than 2 months after a negative advisory committee meeting for the application.
The ATEV therapy, named Symvess, provides revascularization when autologous vein graft or implantation of a synthetic graft is not feasible.
Olezarsen ushers in a new era of care as the first therapy to receive FDA approval for adults with familial chylomicronemia syndrome as an adjunct to diet.
December 19, 2024
Submission of the Biologics License Application seeks approval of lerodalcibep to lower LDL-C in patients with or at risk for ASCVD and primary hyperlipidemia.
December 17, 2024
The Boxed Warning is based on the FDA’s review of a postmarketing case of serious liver injury with fezolinetant reported to the FAERS database.
The FDA has accepted the NDA for TNX-102 SL, a non-opioid, centrally acting analgesic, for the bedtime treatment of fibromyalgia; the PDUFA date still needs to be assigned.
