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FDA approval

Latest Headlines

Latest Headlines

Compounder questions KV's Makena purity claim

Pharmacy services provider PharMerica Corp. is questioning claims made recently by KV Pharmaceutical ($KV.A) that the latter's FDA-approved premature-birth prevention drug Makena provides greater

Report: Senate staffers hammering out accelerated drug approval pathway

BIO and Sen. Kay Hagan (D-NC) are working on draft legislation that would clear a shortcut through clinical trials straight through to the FDA for developers engaged in rare disease drug work,

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