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Approved by the FDA on April 9, 2019, Amgen’s romosozumab-aqqg therapy (Evenity) is indicated for osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
The action requires the company to revise safety information that women and their health care professionals need when considering use of the drug.
Romosozumab-aqqg (Evenity, Amgen) works to decrease the risk of fracture by increasing new bone formation in women with postmenopausal osteoporosis.
This therapy is expected to become available in late June.
Indicating for preventing pregnancy, a statement from the FDA said that loss of efficacy is possible if the user misses tablets.
Many women are unaware of HIV pre-exposure prophylaxis (PrEP) but show a keen interest in spreading the word once they learn about the option, according a recent study in the journal Contraception.
A survey of sexually active women in the United States revealed that 29% experienced challenges in obtaining either a prescription or a refill for hormonal contraception.
Researchers at Kaiser Permanente Washington conducted a qualitative pilot study to understand the experiences and decision-making women face as they contemplate the use of antinausea medications during pregnancy.
Using a drug that increases GABA synthesis and possibly escalates intraneuronal dopamine in a population that is more likely to have behavior health concerns may prove to be an unsafe option.
Officials with the FDA have approved olaparib (Lynparza, AstraZeneca and MSD) for the maintenance treatment of adult patients with BRCA-mutated advanced ovarian cancer.
Hot flashes are a huge problem across the general population, but even more so in breast cancer survivors.
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