The new approvals bring the number of denosumab biosimilars in the US to eight, but price reductions are not yet substantial.
Celcuity expects to complete a rolling NDA submission for gedatolisib under the FDA RTOR program by Q4 2025. Click here to ...
Estrogen is an important hormone in the body, especially for women, and its levels can rise due to various factors, resulting ...
Adding Kisqali (ribociclib) to a nonsteroidal aromatase inhibitor helped patients with hormone receptor–positive, HER2-negative early breast cancer live longer without their disease returning, ...
FDA-approved indications for hormone therapy include moderate to severe VMS, prevention of osteoporosis, and management of premature menopause or early estrogen deficiency. Indirect benefits may ...
A new year means a new Fierce Biotech Fundraising Tracker to record the significant amounts of venture capital being funneled into the industry. We're maintaining the criteria we used for last year's ...
The FDA has proposed removing the boxed warning for menopausal hormone therapy, focusing on local estrogen use and reassessing risks and benefits.
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