The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
The FDA approved Rinvoq (upadacitinib) as the first and only oral Janus kinase inhibitor for the treatment of giant cell arteritis in adults, providing a steroid-sparing option for achieving sustained remission.
Results from a trial reveal that Eli Lilly's tirzepatide, a weight loss drug, reduces the risk of heart failure outcomes by 38% compared to a placebo for obese adults, with significant weight loss and improved symptoms. Novo Nordisk's Wegovy also shows promise in reducing heart failure symptoms.
The U.S. Senate Committee is calling the CEO of Steward Health to testify about alleged corporate greed and financial mismanagement amid the company's bankruptcy.