AcelRx oversimplified Dsuvia’s ease of use, Office of Prescription Drug Promotion says. Focus on opioid safety comes as critics of Janet Woodcock have pointed to FDA’s decisions in the space as disqualifying her for FDA commissioner. Letter appears to reflect long-standing FDA concerns: Dsuvia was approved with a REMS related to administration issues, and Xeris received a similar warning letter last year for exaggerating the ease of use of its glucagon pre-filled syringe Gvoke PFS.

Inrebic, Celgene’s myelofibrosis treatment, and Yuflyma, Celltrion’s high-concentration adalimumab biosimilar, are among the latest new drugs that have been recommended for approval for use across the EU. Meanwhile, TETEC has withdrawn its EU marketing application for Artobend.

Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.

In its second letter of the year, US Office of Prescription Drug Promotion says Xeris Pharmaceuticals’ television ad fails to include important risk information and misleadingly suggests Gvoke pre-filled syringe can be easily used.