Tags : Lyumjev

Insights+: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, […]Read More

Eli Lilly’s Lyumjev (insulin lispro-aabc injection) Receives the US FDA’s

Shots: The approval is based on P-III PRONTO-T1D and PRONTO-T2D studies assessing Lyumjev (insulin lispro-aabc injection, 100 units/mL) and Humalog (insulin lispro injection, 100 units/mL), both in combination with either insulin glargine or insulin degludec in adults with T1D and T2D, respectively Both the studies resulted in meeting its 1EPs of non-inferior A1C reduction @26wks., […]Read More