The FDA recently gave 510(k) clearance to a two-balloon catheter for the targeted delivery of diagnostic and therapeutic agents to the visceral vascular system. This subset of the peripheral vasculature consists of the arteries that supply blood to the intestines, spleen and liver.
FDA reviewers have little doubt that Rockwell Medical's iron-replacement treatment for dialysis patients met its goals in late-stage trials, but the company, seeking agency approval, may have trouble convincing regulators that its Phase III results can translate into real-world benefits.
Novartis believes its new oncology treatment can make a major difference for patients with multiple myeloma, a blood cancer with a particularly grim prognosis. But first it'll have to convince a group of independent experts that the drug's ability to extend survival by a few months outweighs a significant increase in safety risks.
Covidien won FDA 510(k) clearance for its directional atherectomy devices for peripheral artery disease, a notch in the company's belt as it anticipates the close of its pending $43 billion deal with Medtronic.
Hikma recently acknowledged that it had received a warning letter from the FDA for a plant in Portugal. What the drugmaker did not disclose is that some of the warnings were repeats, noted in three previous inspections of the facility dating back a decade.
Forest Laboratories, now a unit of Actavis, has expanded on a recall of one of its key drugs, adding another lot of more than 94,000 cartons of the blood pressure meds to the nationwide retrieval. It is the second recall in three months.
Wockhardt Chairman Habil Khorakiwala waved away suggestions on Monday that his company intends to follow the lead of competitor Ranbaxy Laboratories and sell out because bans by the FDA have seriously devastated its profits.
How bad can an FDA ban on plants be when the U.S. is your primary market? Really bad, India's Wockhardt found out this quarter, with its profit dropping more than $22 million, a 97% freefall.
Medtronic kicked off the commercialization of its Resolute Onyx drug-eluting stent in Europe today. The device will also be launched in selected countries around the world that recognize the CE mark, but not the U.S., where FDA approval is required.
After putting up evidence to show that the liver toxicity triggered by its lead drug can be reversed, the FDA has lifted the full hold placed on its lead--and only--cancer drug. And investors responded enthusiastically to the biotech's return to the clinic, boosting shares by 35% in premarket trading.