Tag:

indacaterol

Latest Headlines

Latest Headlines

Novartis wins FDA OK of low-dose COPD therapy

Two years after the FDA originally stiff-armed Novartis on indacaterol inhalation powder regulators finally gave the COPD treatment a green light at a low dose. Word of the approval spread late on

Novartis delivers promising Ph3 data for combo COPD treatment

Novartis has unleashed a new batch of promising late-stage data for its blockbuster hopeful Onbrez Breezhaler, noting that COPD patients responded better on a combo with Pfizer's Spiriva HandiHaler

Fresh delay for Novartis's indacaterol app

Novartis is going to have to wait a bit longer before it gets final word from the FDA on its marketing app for indacaterol , its experimental COPD therapy. The agency wants an extra three months to

FDA experts turn thumbs down on Novartis's high-dose COPD drug

An FDA advisory committee has given Novartis ( $NVS ) a key endorsement for a low-dose version of its inhaled COPD treatment indacaterol. But analysts fretted over the blockbuster implications of the

Novartis's megablockbuster COPD program faces key hurdle

Early next week Novartis will face a key hurdle in its quest to obtain an approval for a new COPD drug, indacaterol, as FDA experts line up to take a second look at the drug. And analysts say that

Novartis hit with FDA delay on blockbuster COPD drug

Novartis is facing what could be a serious setback on one of its most promising drug candidates. The FDA said today that it will need to see more information on dosing before it can approve