Qiagen won Chinese regulatory approval for a next-generation tuberculosis test and expects a commercial rollout there in the early part of 2014.
The Bay Area's BioMarin Pharmaceutical had an easy time at the FDA, winning the support of an agency panel for its latest rare-disease treatment and feeding expectations for a near-term approval.
Boston Scientific's Vercise deep brain stimulation system isn't yet approved in the U.S., but it continues to rack up regulatory blessings overseas. In the latest advance, the product now has a CE mark to treat a neurological movement disorder known as dystonia.
The FDA has accepted an NDA for Nektar Therapeutics' naloxegol, triggering a $70 million milestone payment from partner AstraZeneca.
With Gilead's pioneering hepatitis C drug sofosbuvir moving closer to a likely approval and a megablockbuster market, AbbVie is looming from behind with some promising results from the first of 6 Phase III studies of its breakthrough triple-threat therapy.
Medtronic began a month ago to recall a number of potentially faulty guidewires used for various cardiac procedures, and now the FDA has slapped the effort with its most-serious "Class I" label. At least one patient has been injured, the company said.
When the European Medicines Agency released its draft policy on clinical trial data disclosure in June, it expected a big response. And it got one, with more than 1,000 comments submitted in the four-month consultation period. Working through this feedback is taking a little longer than expected, though.
BioMarin's drug for a rare enzyme deficiency resulted in a "modest" improvement for patients, according to an FDA staff review, possibly lowering expectations for the company's Tuesday meeting with an agency advisory panel.
Riding high on a surprisingly positive FDA staff review, Vanda Pharmaceuticals and its drug for a rare sleep disorder skated to an expected endorsement from a panel of agency advisers, sending the company's shares up another 20% after hours.
California's NeuroPace gained the FDA's long-awaited signoff for its antiepilepsy neurostimulation implant, capping years of development and testing.