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Less than a week after the FDA halted Juno Therapeutics’ Phase 2 cancer trial over three patient deaths, the agency has given the company the go-ahead to resume the trial. Read More
Less than a week after the FDA halted Juno Therapeutics’ Phase 2 cancer trial over three patient deaths, the agency has given the company the go-ahead to resume the trial. Read More
The FDA is recommending that companies conducting clinical trials on bacterial vaginosis drugs exclude patients with herpes simplex or human papilloma virus, one of dozens of recommendations the agency made on the subject Thursday. Read More
A Delaware federal court ruled that Mylan’s efforts to develop a generic version of Forest Laboratories’ Savella infringed on three of the company’s patents. Read More
A measure to incentivize the development of abuse-deterrent opioids skated through the Senate on Wednesday, with its next stop being the White House. Read More
Despite FDA’s increased efforts to prevent new drug shortages, a large number of drug shortages remain an ongoing problem, a congressional watchdog contends. Read More
Sandoz’s biosimilar of Amgen’s Enbrel has received a recommendation of approval from an FDA advisory committee, making it the second biosimilar to earn recommendation within a 24-hour period.
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