Men And Women’s Health

Reading Time: 3 minutes Understanding the body's hormonal balance is compared to understanding the dance of life, as every hormone in the human body maintains a complex interrelationship with one another. Such a hormonal interplay significantly comes into sharper focus during menopause - a phase marking the cessation of a woman's reproductive ability. This commonly occurs between the age range of 35 to 55. Menopause is a unique condition, as women may suffer from its symptoms for up to a decade during perimenopause before being diagnosed with full menopause. While widely believed that lower levels of estrogen and progesterone are key contributors to menopause...

Reading Time: 3 minutes Mar 4, 2020 Lipocine Inc.'s (LPCN) TLANDO, an oral testosterone product candidate, has been reintroduced and submitted for FDA approval, with a decision date now set for August 28, 2020. TLANDO is promoted as a testosterone replacement therapy in adult males for conditions linked to a deficiency of endogenous testosterone, also known as hypogonadism. Based on the Post Action meeting and written feedback, the FDA indicated Lipocine's approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward.  The FDA requested that the information generated by...