Hormonal

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile. 

Pfizer will talk to regulators about pivotal study designs in cachexia following promising ponsegromab Phase II data, with results from a separate study in heart failure also coming soon.

The company said the results did not meet the threshold for continued capital investment, giving a boost to Spruce Biosciences and its competing congenital adrenal hyperplasia program.

Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

An investigator, an investor and an inventor walk into the New York Stock Exchange, and it’s no joke. Women’s health is a fruitful investment with a clear path to financial return. 

The follow-on Cushing’s product relacorilant has hit in Phase III, and is forecast to lead the market – eventually.    

Five novel agents are among the user fee goal dates coming up in May 2024.