The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification
The companies aim to expand treatment options for millions living with metabolic disorders
LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure
The company will respond to the US FDA within the stipulated timelines
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first
Akero became a wholly owned subsidiary of Novo Nordisk
Adverse events were similar to placebo, and no AP-101-induced antibody responses were detected
Subscribe To Our Newsletter & Stay Updated