Saquinavir's approval in 1995 by the United States Food and Drug Administration (FDA) was a pivotal moment in the fight against HIV/AIDS, marking the first time a protease inhibitor was made available for clinical use. Developed by Roche Pharmaceuticals, Saquinavir represented a crucial advancement in antiretroviral therapy. Protease inhibitors work by inhibiting the protease enzyme that HIV requires to replicate, effectively reducing the viral load in the patient's body and improving their overall health outcomes. This breakthrough provided doctors and patients with a powerful new weapon in the ongoing battle against a disease that had claimed countless lives since its emergence in the early 1980s. The introduction of Saquinavir came at a time when the HIV/AIDS epidemic was at its peak in the United States. The drug was part of a new class of antiretroviral drugs that, along with other treatments, began to reshape the standard of care for HIV-positive individuals. As treatment regimens became more comprehensive and effective, the overall health of patients improved. The dramatic decline in annual AIDS-related deaths within two years post-approval highlighted the impact of Saquinavir and similar drugs in changing the prognosis for individuals living with HIV/AIDS. This new treatment paradigm also spurred further research and development in the realm of antiretrovirals, leading to a wider array of options for clinicians and patients alike. The emphasis on combination therapy with protease inhibitors, nucleoside reverse transcriptase inhibitors, and non-nucleoside reverse transcriptase inhibitors transformed HIV from a death sentence into a manageable chronic condition.