Panel chair Randall Flick said QRxPharma "had not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone."
The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.
Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
Researchers found a correlation between patients feeling involved and how well they stick—if they stick—to their medication regimens.
Phase-III results prompted the drugmaker to pursue a third-quarter filing.
Researchers find public service announcements and physician information don't change minds, but a California practice found one way it could.
Analysts say the Indianapolis, IN, drugmaker's Phase-I results show CDK 4/6 inhibitors will have a role in breast cancer treatment and that Pfizer's palbociclib will not clear the field.
Sunday's data readout has divided the Street between the enthusiastic and the disappointed. The key reason: progression-free survival gains were not as high as anticipated.
The drugmaker is ceasing a trial called MAGRIT after it was unable to identify patients who could benefit from MAGE-A3.