Bristol-Myers Squibb's rare disease treatment metreleptin isn't up to snuff for its desired indication, an FDA committee voted, but agency advisers believe the drug shows some promise in a small subset of patients, giving the drug giant some hope for approval.
St. Jude Medical won a long-awaited CE mark for a larger size of its Portico transcathether aortic heart valve implant, a milestone that expands its overseas market reach and ups competitive pressures on rivals Edwards Lifesciences, Medtronic and Boston Scientific.
When Congress boosted the FDA budget last year to station inspectors in other countries like China, where weak oversight has allowed tainted drug ingredients (and pet treats) into the U.S., China blocked visas for the new regulators. Now, with some intervention from the vice president of the United States, the logjam has been broken.
As an 11th-hour budget deal shapes up for votes in the House and Senate this week, AdvaMed president and CEO Stephen J. Ubl lauded parts of the agreement that call for relief of the FDA user fee sequestration.
The FDA has shrugged off Sprout Pharmaceuticals' female libido drug, further delaying the years-long quest to develop a Viagra equivalent for women, but the drugmaker is appealing the rejection, arguing that the agency is misunderstanding how to measure efficacy.
Tomorrow Merck will take its best shot at convincing a group of FDA advisers that its sublingual allergy pill Grastek deserves a place in the nation's pharmacies.
The FDA will soon add 10 drug inspectors to its office in China to help oversee that country's vast API and drug production industry. If the FDA's experience in India is an indicator, it will mean a raft of enforcement actions in a country that is considered to have weak enforcement by its own agency.
Two years and $100 million removed from a devastating FDA roadblock, Orexigen Therapeutics is again knocking on the agency's door with its weight-loss drug Contrave, filing an NDA with fresh hopes that it wins approval and succeeds in a tough market.
Sanofi's Genzyme snagged a 6-month priority review from the FDA for what could become the first oral treatment for Gaucher disease, a rare genetic disorder that causes abnormal fat buildup in cells, enlarging organs in the body.
In its legal battle with much-larger St. Jude Medical, medical device company AccessClosure will walk away with a concession prize: They escape the threat of an injunction over their vascular puncture technology.