Consider the situation that Shire (ADR) faces with midodrine, a low blood-pressure medication used by about 100,000 patients annually. Shire no longer makes the drug, which has been on the market for
Between FDA and European regulators, we've had three new drug approvals in 24 hours. That should give drug-launch aficionados plenty to contemplate over the weekend, even if they're trapped inside by
Three years after dismissing an application for Firazyr (icatibant) after citing the company for insufficient trial data, regulators at the FDA this morning stamped Shire's ($SHPGY) new drug for
Yet another $100,000-plus cancer treatment will soon hit the market. Seattle Genetics, which won early FDA approval for its new lymphoma drug Adcetris, has tagged it with a $13,500-per-dose price,
Seattle Genetics ($SGEN) has crossed the finish line. The FDA has granted the biotech an accelerated approval for Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma. While it's
The FDA came through with an early approval for Roche's new melanoma drug Zelboraf and the diagnostic test that targets it. The drug works on patients with a BRAF mutation, which amounts to about
In a rare move, the FDA has stamped an early approval on Roche's remarkable new melanoma drug, vemurafenib, giving it a green light on a potential new blockbuster two months ahead of its PDUFA date.
Collaborators at Johnson & Johnson and Gilead have won FDA approval of a new combo treatment for HIV expected to earn more than a half billion dollars a year. The agency announced yesterday
Studying the numbers on new-drug launches is a bit like parsing sports statistics. Some athletes are consistent-if-not-inspiring performers; others have hot streaks that run cold. Others take a
After a knock-down at FDA on Tuesday, AstraZeneca ($AZN) got a leg up yesterday with the approval of its blood thinner Brilinta. It's been a long road, and the FDA nod isn't without its caveats.