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South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
Canadian drugmaker Tekmira has stopped recruiting patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
More than a year after being rejected by the FDA, The Medicines Company’s intravenous antiplatelet drug Kengreal has received the go-ahead as a post-angioplasty anticlotting agent. Read More
An interim Phase 3 analysis of idarucizumab shows the drug reverses the anticlotting effect of Pradaxa within minutes in patients requiring urgent procedures or with serious bleeding complications, Boehringer Ingelheim reports. Read More
Mylan is expanding its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests. Read More
Israeli drugmaker Teva will pay $24 million to settle a pay-for-delay lawsuit over its generic version of AstraZeneca’s heartburn relief drug Nexium. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market. Read More
Buyers of heartburn drug Nexium are seeking an injunction against Ranbaxy and AstraZeneca in pay-for-delay litigation, arguing that their motion is supported by a recent Second Circuit ruling upholding an injunction requiring Actavis to keep an older version of Alzheimer’s drug Namenda on the market. Read More
Drugmakers and patients can now access risk evaluation and mitigation strategies for FDA-approved drugs, thanks to an updated website launched by the FDA on June 17. Read More