Are 'breakthrough' drugs as safe as other FDA-approved medicines? [CNN]
Bristol-Myers Squibb Company (BMY)
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Source: CNN
Are 'breakthrough' drugs as safe as other FDA-approved medicines? (CNN) New research questions the quality of drugs given the "breakthrough therapy" designation by the US Food and Drug Administration. In late 2012, the FDA created this designation to speed the process for reviewing not-yet-approved experimental medicines intended to treat serious or life-threatening conditions. Commonly, the clinical trials supporting breakthrough drugs lack some of the scientifically rigorous features found in the research backing drugs that have not been granted that designation, a new study published in Tuesday in JAMA found. "I think the FDA, as directed by Congress, is doing everything it can to expedite the development and review of drugs that treat serious and life-threatening conditions," said Dr. Joseph S. Ross, a co-author of the study and associate professor at the Yale University School of Medicine. "Our research suggests that FDA approval of these breakthrough therapies is generally base
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BMY
Earnings
- 2/2/24 - Beat
BMY
Sec Filings
- 4/2/24 - Form 4
- 4/2/24 - Form 4
- 4/2/24 - Form 4
- BMY's page on the SEC website