Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi's bid for more OTC meds gets FDA boost

Sanofi may soon have another allergy drug to add to its over-the-counter stable. FDA reviewers backed Nasacort AQ as safe for use without a prescription,  Reuters reports, ahead of an advisory panel meeting Wednesday.

Mercator snags FDA patent for blood-pressure drug delivery catheters

Mercator MedSystems pulled in a new FDA patent for its micro-infusion drug delivery devices for renal denervation and carotid body modulation procedures as a treatment for high blood pressure.

FDA's first-time PMAs down drastically so far in 2013

The FDA granted only 9 first-time premarket approvals in the first half of 2013 and a single humanitarian device exemption, EP Vantage notes in a new report. That's a 47% drop from 19 PMAs issued in the first half of 2012.

GE recalls scanners after patient crushed to death

GE Healthcare is urging customers to stop using more than 20 models of its nuclear imaging devices until the company can inspect each one and ensure it's not prey to the same problem that killed a patient in the U.S. last month.

InSightec takes to China with uterine fibroid device

Israel's InSightec won Chinese approval for its noninvasive uterine fibroid treatment, clearing the company to market its ultrasound-powered device in the fast-growing market.

Novartis COPD drug gets European backing

Swiss pharma giant Novartis has earned an endorsement from the European Committee for Medicinal Products for Human Use for it once-daily Ultibro Breezhaler to treat chronic obstructive pulmonary disease.

Europe probing Germany's practice of cutting break on fees to some drugmakers

Germany's pricing agency has rejected offerings right and left, and drugmakers say it is getting increasingly hard to make any money in the country. But it turns out that at the same time it has been turning its back on some players, the government has been cutting a break to financially struggling German companies.

Forest Labs wins FDA approval for antidepressant Fetzima

Forest Laboratories took another step forward in rebuilding its antidepressant business with the FDA's approval of Fetzima for major depressive disorder (MDD) in adults. Fetzima, discovered by France's Pierre Fabre Laboratories, is a once-daily serotonin and norepinephrine reuptake inhibitor.

Cepheid wins FDA nod for combo TB test

California's Cepheid secured the FDA's blessing to market its Xpert MTB/RIF assay, the U.S.'s first test that can detect both bacteria that cause tuberculosis and whether a patient's strain is resistant to antibiotic therapy.

Novartis' Bexsero left off U.K. immunization schedule

Novartis' Bexsero may be the only vaccine approved for life-threatening meningitis B, but that wasn't enough to convince the U.K.'s Joint Committee on Vaccination and Immunisation to add it to Britain's routine vaccination schedule.