The FDA's Arthritis Advisory Committee (AAC) on Oct. 23 in a 10-4 vote recommended approval of lesinurad, an experimental drug from AstraZeneca plc and its US unit Ardea Biosciences Inc., as a treatment in combination with a xanthine oxidase inhibitor (XOI), such as allopurinol or febuxostat, for hyperuricemia associated with gout in adults.
The FDA's Arthritis Advisory Committee (AAC) on Oct. 23 in a 10-4 vote recommended approval of lesinurad, an experimental drug from AstraZeneca plc and its US unit Ardea Biosciences Inc., as a treatment in combination with a xanthine oxidase inhibitor (XOI), such as allopurinol or febuxostat, for hyperuricemia associated with gout in adults.
But that nod came with much anguish and many caveats, with a majority of the AAC calling for postmarketing studies...
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
The IL-4/13 inhibitor was approved in the US for COPD, a blockbuster-sized indication, but the commercial ramp could take time and several competitors are on its heels.
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.
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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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