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The FDA has approved Reblozyl as first-line treatment in MDS-related anemia and the first generics of ADHD drug Vyvanse. The agency also issued a CRL for bevacizumab to treat wet AMD. Additionally, two companies have submitted supplemental applications. These include Janssen, which is seeking full approval for Balversa for urothelial carcinoma, and AbbVie, which is seeking approval of Skyrizi for ulcerative colitis.

Proponents hailed yesterday's announcement of the first 10 drugs subject to Medicare "maximum fair price" starting in 2026 as ushering in an era of lower drug prices and a political victory over pharma. Critics said it is price controls masquerading as negotiation and would smother innovation in one of the most innovative industries in the U.S.

The FDA has approved the first biosimilar of MS drug Tysabri and granted additional approvals to Abrysvo to prevent RSV in infants, to a higher dose Eylea, and to Ingrezza for a disorder associated with Huntington’s disease. The agency has also set a review date for first-in-class therapy for MDS and granted priority review to Xtandi for earlier treatment in prostate cancer.

The rise in the volume, variety and complexity of tests holds great promise for improving healthcare for patients, but also poses challenges for providers and health plans

It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.

In an episode of Managed Healthcare Executive’s “Between the Lines” video series, Leslie Cho, M.D., and Seth Shay Martin, M.D., M.H.S., discussed bempedoic acid, the CLEAR Outcomes trial and the implications for cardiovascular disease prevention.