September 28, 2010

Keryx has begun its phase-3 clinicial trial of a drug designed to treat elevated serum...

September 27, 2010

The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture...

September 27, 2010

GlaxoSmithKline Consumer Healthcare is urging the Food and Drug Administration to remove smokeless tobacco products...

September 27, 2010

The Food and Drug Administration has approved a generic version of a drug for a...

September 26, 2010

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...

September 26, 2010

The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals....

September 26, 2010

More than a dozen top Food and Drug Administration officials will meet with generic drug...

September 26, 2010

Federal efforts to simplify and standardize the information that patients receive with their prescription medications...

September 26, 2010

Winc Design is launching its Charlie Banana brand of environmentally friendly cloth diapers and baby...

September 26, 2010

The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone...

September 26, 2010

Greenstone announced the launch of an authorized generic version of the Alzheimer’s disease drug Aricept...

September 23, 2010

An investigational diabetes drug works as well as a generic already on the market, according...

September 22, 2010

The Food and Drug Administration has approved a manufacturing plan for a drug to treat...

September 22, 2010

The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug,...

September 22, 2010

The Food and Drug Administration has moved to significantly restrict access to a controversial diabetes...

September 21, 2010

The Food and Drug Administration has approved a drug for reducing relapses in patients with...

September 21, 2010

The Food and Drug Administration has granted priority review to an opioid painkiller designed to...

September 20, 2010

A Food and Drug Administration advisory committee has recommended approval of a drug for patients...

September 20, 2010

A coalition of lobbying groups urged the Senate on Monday to review and pass pending...

September 20, 2010

The Food and Drug Administration has approved a generic treatment for organ transplant patients....

September 20, 2010

The Food and Drug Administration is looking for input on regulations concerning knock-off versions of...

September 19, 2010

Biotech company Genentech has amended its application to the Food and Drug Administration seeking an...

September 16, 2010

Emergent BioSolutions has landed a $51 million contract from the Department of Health and Human...

September 16, 2010

The Food and Drug Administration has accepted for review a regulatory approval application for a...