Regulatory
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
The FDA’s Center for Biologics Evaluation and Research is aiming to recreate the success achieved with the rapid development of COVID-19 vaccines under a program of the same name.
This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
The regulator found no issues with mirikizumab’s clinical or safety data.
Liver toxicities triggered a partial clinical hold on Merck KGaA’s trial studying its BTK inhibitor candidate for multiple sclerosis.
In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
The Inflation Reduction Act contains provisions designed to influence drug prices. These policies might affect drug development and the prioritization of new drugs.
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