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HHS on Friday submitted its proposed rule on prescription drug imports — a key part of the administration’s strategy to lower drug prices — to the Office of Management and Budget (OMB) for review. Read More
The approval makes the drug the only once-daily PARP inhibitor approved as a monotherapy treatment for recurrent ovarian cancer beyond those with a BRCA mutation. Read More
Multiple states accused RB Group and its former subsidiary Indivior of falsely promoting Suboxone as less susceptible to diversion and abuse. Read More
In an Oct. 28-31 meeting, the EMA’s pharmacovigilance risk assessment committee (PRAC) warned against the use of Sanofi’s multiple sclerosis drug Lemtrada (alemtuzumab) in patients with certain heart, circulation, bleeding or auto-immune disorders besides multiple sclerosis. Read More
The generic manufacturers are accused of “routinely and systematically” communicating with each other to determine their market share and customers. Read More