Issued with a complete response letter from the FDA, the company says it will now submit newer data showing the combination's effects on exacerbations.
AstraZeneca PLC’s goal of challenging GlaxoSmithKline PLC's lead in chronic obstructive pulmonary disease has been dealt a blow after the US Food and Drug Administration rejected its new triple therapy combination, PT010.
Also known as Breztri Aerosphere in Japan, where the drug was approved in June, the company has disclosed that the...
After the failure of its lead asset in a Phase II trial earlier this year, Korea's Bridge Biotherapeutics has accepted an acquisition offer from bitcoin group Parataxis.
Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.
The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.
In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.
The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.
As competition heats up and the obesity market matures, the two frontrunners are tailoring their studies to the wants and needs of different patient groups.
The off-the-shelf stem cell therapy shows sustained glycemic control and a high rate of insulin independence.
