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The FDA will allow Ariad Pharmaceuticals to resume U.S. sales of its leukemia drug Iclusig, but the drugmaker must now implement a host of stringent safety measures designed to address the drug’s risk of blood clots. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in a recent SEC filing. Read More
Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More
The FDA has denied Éclat Pharmaceuticals’ unorthodox request for the agency to shut down competitors the company says are making unapproved versions of its medicine. Read More
GlaxoSmithKline unveiled a new compensation system for its global sales force this week in a move hailed as a revolutionary change to improve ethical practices for drug sales professionals. But so far it’s a revolution of one. Read More
The FDA has denied Public Citizen’s petition to withdraw prescription weight loss drug Xenical and its OTC equivalent Alli from the market, disagreeing with the government watchdog’s concerns that the products cause severe liver damage and offer few benefits. Read More
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More
The European Medicines Agency (EMA) has indefinitely postponed a controversial plan to begin releasing to the public detailed information from clinical study reports contained in new drug applications, the central element to its clinical trial transparency initiative. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. Read More