FDA Accepts Application for Antibiotic for Drug-Resistant InfectionsDecember 2nd 2022
SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.
FDA Accepts sBLA for Evkeeza for Children with Rare High CholesterolNovember 30th 2022
If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.
FDA Approves First Drug that Delays DiabetesNovember 18th 2022
Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.