Regulatory Affairs Syndicator

Ireland’s leading drug maker Elan Corp. PLC, which is awaiting a verdict from U.S. regulators on a key suspended drug, reported narrower net losses Tuesday and expressed hopes of a rebound this year.

Lipid Sciences Inc. said Tuesday that it has received the Food and Drug Administration’s conditional approval to test a device that filters cholesterol from a patient’s blood.

Lipid Sciences got the Food and Drug Administration’s conditional approval to test a device that filters cholesterol from a patient’s blood.

The company’s performance precedes two upcoming decisions later this year that will greatly impact its financial future.

The FDA today approved Amitiza (lubiprostone), the first drug of its chemical type, for the treatment of chronic constipation in the adult population where there is no known cause for the condition.

The FDA today approved Amitiza (lubiprostone), the first drug of its chemical type, for the treatment of chronic constipation in the adult population where there is no known cause for the condition.

The mammography facilities the state Department of Environmental Protection inspected during the fourth quarter of 2005 were found to be operating within guidelines set by the U.S. Food and Drug Administration, DEP Secretary Kathleen A.

Elite Pharmaceuticals Inc. on Tuesday said the Food and Drug Administration has accepted its investigational new-drug application for OxyQD, its once-a-day oxycodone painkiller.

An experimental, but promising, therapy aimed at improving vision in people with macular degeneration is being tested in a local study, allowing participants to get the drug while it’s being reviewed by the Food and Drug Administration.

Ireland’s leading drug maker Elan Corp. PLC, which is awaiting a verdict from U.S. regulators on a key suspended drug, reported narrower net losses Tuesday and expressed hopes of a rebound this year.

An experimental, but promising, therapy aimed at improving vision in people with macular degeneration is being tested in a local study, allowing participants to get the drug while it’s being reviewed by the Food and Drug Administration.

Elite Pharma drug application acceptedBusinessWeek - 2 hours ago… on Tuesday said the Food and Drug Administration has accepted its investigational new-drug application for OxyQD, its once-a-day oxycodone painkiller. … FDA Accepts IND for Eli…

Elite Pharmaceuticals Inc. on Tuesday said the Food and Drug Administration has accepted its investigational new-drug application for OxyQD, its once-a-day oxycodone painkiller.

CORRECTING and REPLACING FDA Clears GenExel-Sein's DUO-CARE(TM) …Genetic Engineering News, NY - 2 hours agoannounced today that it has received US Food and Drug Administration (FDA) 510k clearance for DUO-CARE(TM), a device that combine…

Quigley Corp. said Tuesday that the Food and Drug Administration cleared the company to study its experimental anti-inflammatory drug in dogs.