First-time generic drug approval, September 2009: Tacrolimus capsules

The FDA is conducting an ongoing inspection of a third-party filler.

Jardiance is currently available to treat patients with type 2 diabetes, end stage renal disease and heart failure. It has a list price of $570.48 for a month supply.

Developing novel drugs to treat cancer remains a strong focus for drug developers. Several first-in-class therapies have become available over the last few months.

The FDA has requested an additional study. ARS Pharmaceuticals plans to appeal the decision.

Atidarsagene autotemcel is a one-time gene therapy to treat patients with the rare and fatal disease metachromatic leukodystrophy (MLD). The agency has set a review date of March 18, 2024.

Earlier this year, RedHill Biopharma began a warranty program for patients taking Talicia, with a commitment to reimburse patient out-of-pocket costs if Talicia does not work.