FDA approval

Latest Headlines

Latest Headlines

Bayer, J&J's Xarelto wins key FDA nod, with warning

Bayer and Johnson & Johnson ($JNJ) snagged the crucial stroke-prevention indication for their new clot-fighter Xarelto. The FDA approval isn't without its caveats, however. FDA may have granted

J&J wins blockbuster approval to market Xarelto for stroke prevention

The FDA has given Johnson & Johnson ($JNJ) the green light to market Xarelto to prevent stroke among patients suffering from atrial fibrillation--opening up a blockbuster market involving more

Lilly's ED treatment Cialis wins prostate indication

Eli Lilly ($LLY) just won FDA approval for an enlarged-prostate treatment. That's a bit of good news that only goes so far, as the market for benign prostatic hyperplasia treatments is rather full.

Drug in regulatory limbo a headache for Shire, FDA

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

New drug nods for J&J, Lilly/BI, and Shire

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

Shire battles back to win FDA OK for HAE drug Firazyr

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

Seattle Genetics prices Adcetris above $100K

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,

UPDATED: FDA pins approval on Seattle Genetics' cancer drug Adcetris

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

Roche melanoma drug wins early FDA nod

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

Roche wins early approval for blockbuster melanoma drug vemurafenib

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.