FDA approval

Latest Headlines

Latest Headlines

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.

FDA green lights combo HIV drug from J&J, Gilead

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

Merck, Novartis top drug-approval rankings

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

Now that Brilinta's approved, AZ has to sell it

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.