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Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. Read More
A New Jersey drug coating company hasn’t paid its generic drug facilities fees for the last two fiscal years, making every product it helps to manufacture automatically mislabeled, the FDA warned. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. Read More
Regulators in Canada are revising the dispute resolution process for drugmakers appealing rulings on drug applications, eliminating some available appeals categories and changing what body is responsible for reviewing the disputes. Read More
Rigel Pharmaceuticals said Wednesday it will not initiate any new studies of R348 for the treatment of dry eye disease, after the compound failed to meet its primary and secondary endpoints in a recently completed Phase II trial. Read More