Shah, whose company developed the oral testosterone drug Kyzatrex, urged regulators to broaden treatment access and align policy with modern science and preventive healthcare goals.
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Marius Pharmaceuticals, which helped secure FDA removal of Black Box Warning, says regulatory shift marks a milestone for patient access and treatment options.
Marius CEO Shalin Shah says his company is challenging outdated perceptions, expanding access to testosterone treatment, and driving innovation in hormone therapy
The campaign seeks to illuminate the impact of testosterone deficiency on men’s health.
Hypogonadism, a condition characterized by low testosterone levels, has become increasingly prevalent in the United States.
Kyzatrex could be a potential blockbuster to treat testosterone deficiency, a severely undertreated disease. Â