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In another Alzheimer’s disease therapeutics payment slapdown, the Centers for Medicare and Medicaid Services (CMS) rejected a petition by the Alzheimer’s Association to expand coverage of antiamyloid antibody therapy, but left the door open to reconsidering the idea in the future. Read More
The number of drug applications that the FDA has received involving artificial intelligence (AI) and machine learning (ML) tools jumped from just a handful before the COVID-19 pandemic to more than 120 in 2021 and topped 150 in 2022.
The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection to treat patients with geographic atrophy secondary to age-related macular degeneration, a condition that is a leading cause of blindness. Read More
The FDA has granted Accelerated Approval (AA) to Travere Therapeutics’ Filspari (sparsentan) to reduce proteinuria (high levels of protein in the urine) in adults at risk of rapid progression of the rare kidney disease primary endothelin-1 and angiotensin II (IgAN). Read More
The FDA required a boxed warning with the product that some patients treated with Lamzede have experienced hypersensitivity reactions, including anaphylaxis. Read More
The FDA has issued two complete response letters (CRL) to Phathom Pharmaceuticals, one for a new drug application (NDA) for its acid suppressant vonoprazan for treating erosive esophagitis and another for a postapproval supplement for Voquezna, a combination therapy previously approved for treating Helicobacter pylori infections. Read More