FDA approval

Latest Headlines

Latest Headlines

Spike in approvals can't quell industry protests about the FDA

Throughout 2011 you could hear a growing chorus in the biopharma industry complain bitterly about the tougher regulatory challenges facing drug developers. Antibiotics got tougher. Diabetes got

UPDATED: FDA panel recommends approving Alexza's inhaled antipsychotic in split vote

An FDA panel of experts recommended approval for Alexza Pharmaceuticals' ($ALXA) inhaled, fast-acting antipsychotic drug Adasuve, as long as the company limits the dose to once a day and follows

Ranbaxy drama shows manufacturing impact on pharma business

That loud ticking noise must have been stressful for Ranbaxy executives yesterday. For most of the day, it appeared to the outside world the massive generic- Lipitor market opportunity was passing

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