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The FDA’s agenda includes an advisory committee meeting for Sarepta’s delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.
Despite multiple therapeutics approved to treat localized symptoms, there are currently no systemic therapies on the market for Sjogren’s syndrome.
As the COVID-19 market dries up, Moderna looks to FDA approval of its other vaccines including a 2024 commercial launch of its investigational RSV vaccine for older adults.
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.
Data from Phase III confirmatory MIRASOL trial show antibody-drug conjugate boosts survival in platinum-resistant ovarian cancer, setting the stage for full approval by the FDA.
The regulatory decision marks a turning point in the RSV race in what’s expected to be a competitive space.
Despite the Phase III failure, Travere and partner CSL Vifor will explore potential regulatory paths for sparsentan as a treatment for focal segmental glomerulosclerosis.
Many employers aren’t offering the high salaries employees had grown accustomed to in recent years, leaving workers to decide whether they should accept a pay cut.
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter.
The company’s pipeline changes come as it weathered a nearly 30% decline in first-quarter revenues due to a slowdown in its COVID-19 business.
In addition to promoting their brands, companies say their funding initiatives give them access to the expertise of top researchers and contribute to society.
