(Reuters Health)—Many high-risk therapeutic devices get U.S. Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the devices work once they are on the market are also few and far between, according to a new study that looked at all 28 high-risk…
FDA Investigates MRI Safety after Studies Find GBCA Deposits in Brain
The FDA is investigating the safety of MRIs using gadolinium-based contrast agents, which recent studies have shown may leave deposits of those chemicals in patients’ brain tissue after multiple scans…
Brentuximab Vedotin Enters Phase 2 Trials & More
Phase 2 clinical trials have begun to assess the safety of brentuximab vedotin for the treatment of SLE. Also, the FDA is reviewing an application for a once-daily tofacitinib citrate tablet to treat RA…
New Analysis Underscores Improving Pharma R&D Productivity
LONDON (Reuters)—Drug industry productivity is continuing to improve, with a bumper haul of new products being launched and companies proving more successful in the final stages of clinical testing, according to a new analysis. Data from Thomson Reuters published on Tuesday showed the number of innovative medicines, or new molecular entities, launched globally in 2014…
FDA Issues Stronger NSAIDs Warning
The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction…
Some Serious Drug Side Effects Not Reported to FDA Within 15 days
(Reuters Health)—Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds. Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths…
Most Rheumatologists Want FDA to Better Regulate Biosimilars
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…
Abaloparatide-SC May Reduce Fractures for Osteoporosis & New FDA Safety Website
In a 25 month Phase 3 trial, abaloparatide-SC reduced the risk of new fractures in patients suffering from postmenopausal osteoporosis. Plus, the FDA launches a new drug safety website.
U.S. House Passes Bill to Speed New Drugs to Market
WASHINGTON (Reuters)—The U.S. House of Representatives on Friday passed a bill aimed at speeding new drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it. The House voted 344 to 77 in favor of the bill, known as the 21st Century Cures Act, which would require the FDA to streamline the…
FDA Strengthens Warning Label for Certain Antiinflammatory Drugs
(Reuters)—The U.S. Food and Drug Administration is strengthening an existing warning label that non-aspirin, non-steroidal antiinflammatory drugs (NSAIDs) increase the risk of heart attack or stroke. NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib, all of which carry FDA warning labels. The agency said it would require updates to the labels of prescription and over-the-counter (OTC)…
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