The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.
The US Food and Drug Administration will convene its Endocrinologic and Metabolic Drugs Advisory Committee to review a critical labeling expansion for Amarin Corp. PLC's Vascepa (icosapent ethyl) for the treatment of severely high triglycerides, likely delaying approval of a supplemental new drug application (sNDA) based on the company's REDUCE-IT cardiovascular outcomes trial.
Amarin said after the stock market closed on 8 August that the US FDA informed the company it will hold...
A disastrous Phase II miss for the pulmonary arterial hypertension candidate AV-101 leaves Aerovate drifting. Could Gossamer stand to benefit?
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
CEO Bill Anderson would not be drawn on whether the drug, currently approved for chronic kidney disease associated with type 2 diabetes, will hit a previous forecast of €3bn peak sales, but expansion into heart failure may make that figure look conservative.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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