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The PRIME designation was based on clinical data from a Phase I resection study in patients with recurrent brain cancer and results from preclinical models. Read More
Sterility concerns and other deficiencies at a Maryland drugmaker could be putting patients at risk, the FDA told Option Care Enterprises in Columbia, Md. in a July 20 warning letter. Read More
A Pennsylvania federal court ruled that 11 generic manufacturers, including several subsidiaries of Teva Pharmaceuticals, must answer to a class-action lawsuit claiming they violated state consumer protection and unfair trade practice laws by inflating their prices. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
Celgene reached a civil settlement with the Department of Justice and 28 states, as well as Washington D.C. and the city of Chicago, agreeing to pay $280 million to resolve a case over off-label marketing claims for two cancer treatments — Thalomid (thalidomide) and Revlimid (lenalidomide). Read More
FDA Commissioner Scott Gottlieb sought to assure agency staff this week that Congress will reauthorize its user fee programs before the Sept. 30 deadline, which promise to provide the agency more than $1.4 billion in funding for reviewing activities and staff salaries in the next fiscal year. Read More