Topic:

Regulatory

Latest Headlines

Latest Headlines

Can Rockwell Medical win FDA approval for its dialysis drug?

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 gears up for FDA scrutiny with a new blood cancer drug

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 gets FDA nod for directional artherectomy system for peripheral artery disease

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.

FDA warning cites Hikma plant for repeatedly failing to investigate issues

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 recalls another 90,000-plus bottles of Bystolic

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.

Chairman says Wockhardt has no plans to sell

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.

India's Wockhardt profit freefalls as FDA bans devastate U.S. sales

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 announces launch of new drug-eluting stent following CE mark

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.

Geron shares rocket up after FDA takes the cuffs off its lead drug

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.

Boehringer gets NICE nod for Pradaxa for DVT/PE in U.K.

Boehringer Ingelheim has completed a trifecta of approvals for its blood thinner Pradaxa for deep vein thrombosis and pulmonary embolism. The U.K. cost watchdog NICE has now given it a thumbs up after the FDA and the European regulators did the same thing this year.