The FDA played no favorites in the idiopathic pulmonary fibrosis (IPF) space – approving two new medicines on the same day on 15 October for the fatal lung disease, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), despite the different timelines the drugs were on for the agency's nod.
The FDA played no favorites in the idiopathic pulmonary fibrosis (IPF) space – approving two new medicines on the same day on 15 October for the fatal lung disease, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), despite the different timelines the drugs were on for the agency's nod.
Both Esbriet and Ofev were approved for the US market well-ahead of their Prescription Drug User Fee Act action dates...
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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