Adamis Gets Another CRL For Opioid Overdose-Reversal Drug
Adamis got its second complete response letter for Zimhi. While not apparently related to the first, it may complicate the company's outlook following a lackluster quarter.
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Keeping Track: Approvals For Phexxi, Kynombi; New Claims For Lynparza, Alunbrig, Tecentriq; Intercept May Miss NASH User Fee Date
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
Details of action letters issued by US FDA, regularly updated with new announcements.
Together with a similar delay for AbbVie’s Rinvoq, the delays appear to stem from a study that raised concerns about the class. But the potential sales impact is less clear.