Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more
On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more
On March 27, 2017, the U.S. Food and Drug Administration approved the use of the poly ADP-ribose polymerase (PARP) inhibitor, Zejula (niraparib), for the maintenance treatment of recurrent ovarian, fallopian tube, or primary...more