FDA Pre-IND meeting
Shorla Pharma have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (‘FDA’) on our oncology drug SH-105. The FDA’s prompt and definitive response confirms our clinical and regulatory strategy and aligns with our plan to accelerate the filing of our New Drug Application (‘NDA’). This positive outcome strengthens our efforts to bring SH-105 to market benefiting women suffering from breast and ovarian cancer. A significant milestone on Shorla Pharma’s journey of bringing innovative oncology products to market.