Hematological Disorders

The US FDA for the third time has refused to give approval to Lipocine’s oral testosterone drug, Tlando. The drug is an oral testosterone replacement therapy in clinical trials for the treatment of Primary and Secondary hypogonadism in males. The drug contains containing Testosterone Undecanoate (TU) which helps in restoring normal levels of testosterone. This is the third time the drug has been disapproved by the regulatory body as the therapy failed to meet the three secondary goals. This led to the falling of the company’s shares to a record low to 34%. In a review by Sterling et al. titled "Hypogonadism: Easy to define, hard to diagnose, and controvers...