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.
After a scathing staff review, Sanofi walked away from an FDA panel with mixed messages on its long-delayed multiple sclerosis drug, as agency advisers said the injection wasn't too risky to approve but took issue with the drugmaker's trial design.
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics (and Johnson & Johnson.
So far this year the FDA has approved 27 new drugs, fewer than last year's total. But a greater focus on real medical breakthroughs will make this year's crop far more valuable than the harvest of 2012, according to EP Vantage.
Boston Scientific is ticking closer to judgment day for its much-scrutinized Watchman device, securing an FDA advisory hearing for a stroke-fighting implant that has faced doubts throughout its development.
The FDA has applied its most serious label to Atossa Genetics' recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.
Despite fewer drug approvals overall compared to last year, this year will have turned out a new crop of blockbusters whose combined revenues 5 years out are forecast to reach $18.7 billion, besting last year's record of $16.4 billion in projected sales, according to a report released today by EP Vantage.
The National Institute for Health and Care Excellence nixed Johnson & Johnson's Velcade as too expensive in comparison with the current standard therapies--at least as far as the current data can show.