Pink SheetThe quiet end for Zohydro ER – buried in a list of drugs whose approvals are being withdrawn by the US FDA – belies the turmoil the opioid created for the agency. FDA announced in a Federal Register
Pink SheetArdelyx Inc. is preparing to join the small group of sponsors challenging US FDA complete response letters through the formal dispute resolution process – a process that sees more appeals denied than
ScripScrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker. AzurRx Will Take First Wave Name After
Pink SheetThe US Food and Drug Administration closed out the week with a late-Friday approval of Esperion Therapeutics Inc. ’s Nexletol, a new oral non-statin LDL-cholesterol lowering agent. Earlier in the wee