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Pfizer will ask the FDA to approve its respiratory syncytial virus vaccine, RSVpreF, based on phase 3 data showing that it prevented about 86 percent of severe disease. Read More
The FDA issued a warning letter to Tramadol US, calling on the company to stop selling prescription drugs, including opioids, directly to consumers on the 25 websites the company operates. Read More
A federal judge in California has ruled that Gilead Sciences must face a pay-for-delay lawsuit over alleged unlawful payments to India-based Cipla to block competition for Gilead’s former blockbuster HIV drug Truvada (emtricitabine, tenofovir disoproxil fumarate). Read More
Indivior must face a federal jury over allegations that it tried to maintain its monopoly on Suboxone by switching to a sublingual formulation just as other companies were launching generic versions of the opioid antagonist. Read More