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The FDA has said no to Cytokinetics’ new drug application (NDA) for omecamtiv mecarbil, an investigational treatment for heart failure with reduced ejection fraction (HFrEF). Read More
The European Medicines Agency’s (EMA) human medicines committee has endorsed eight new drugs for approval following its February monthly meeting. Read More
The FDA has granted Fast Track designation to Icosavax’s IVX-A12, an innovative investigational bivalent vaccine that targets both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Read More
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