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Two FDA advisory committees grappled with the proposed addition of information from a pediatric study to labels for Purdue Pharma’s opioid patch Butrans (buprenorphine), without coming to a clear consensus. Read More
The U.S. government sided with Sandoz on the residual claims from the biosimilar manufacturer’s Supreme Court case with Amgen — arguing the federal law outlining the biosimilar approval process should preempt state laws on the topic. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Read More
Missouri’s Supreme Court upheld a $38 million verdict against Abbott Laboratories over claims its epilepsy drug Depakote caused birth defects. Read More
In the 1980s, heart medications accounted for 27 percent of all new drug approvals in the U.S. — a share that dropped by more than half in 2010-2016. Read More
Recent action from a state legislature, as well as objections from industry groups, suggest the FDA should narrow its guidance for off-label claims, according to two prominent labeling attorneys. Read More
The FDA updated its nearly 15-year-old policy on performing environmental assessments and reviewing potential exclusions under the Office of Pharmaceutical Quality. Read More