FDA to review MGI Pharma’s Aquavan
The new drug application (NDA) for Aquavan was submitted to the FDA on September 27, 2007. The acceptance for review of the NDA represents the FDA’s determination that
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eli Lilly and Company’s (Lilly) olomorasib as a potential treatment for adults with advanced pancreatic cancer who have already received at least one prior systemic therapy.
The trial will evaluate MP470 in combination with several standard of care chemotherapy regimens, including carboplatin/paclitaxel, carboplatin/etoposide, docetaxel, topotecan and erlotinib. The trial is expected to enroll up
Ambrx said that the collaboration will apply its protein optimization technology, ReCODE, with Lilly’s expertise in biologics discovery, development and commercialization to pursue first-in-class or best-in-class drug candidates,