The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters.
A delay in the user fee deadline for Bristol Myers Squibb Company’s cardiac drug mavacamten over a proposed risk evaluation and mitigation strategy (REMS) could involve the need for additional monitoring, the company told Scrip. It remains to be seen if the REMS requirements could diminish mavacamten’s profile versus a competitor with a similar mechanism of action.
The 90-day extension of the US Food and Drug Administration review deadline, announced 19 November, shifts the action date for...
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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