Amgen Inc. began to close the book Tuesday on several federal investigations and whistleblower suits involving its marketing practices when it pleaded guilty in federal district court to a misdemeanor charge of off-label marketing of Aranesp, which posted global sales of $2.3 billion in 2011.

With one piece of the budget puzzle about to be put in place, at least temporarily, the FDA, National Institutes of Health (NIH) and other federal agencies can start planning for fiscal 2013, which begins in two weeks.

Questioning the acceptance of serum sodium changes as a surrogate endpoint for hyponatremia drugs, the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) wasn't sold on the clinical efficacy of Cornerstone Therapeutics Inc.'s lixivaptan.

Drugmakers going into emerging markets are finding that what looks clear on paper may not be so in practice.

Cornerstone Therapeutics Inc. will put its acquisition of Cardiokine Inc. to the test Thursday as it debuts Cardiokine's lone compound, lixivaptan, for the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

The looming spending sequestration, scheduled to take effect Jan. 2, has left a big question mark hanging over activities at the FDA, National Institutes of Health (NIH) and other federal agencies.

As the cost of conducting clinical trials helps drive drug prices beyond the wallet of many U.S. patients, the Department of Health and Human Services (HHS) is looking for ways to streamline those trials.

While having, in effect, only one controlled trial to support approval of Novartis AG's TOBI Podhaler (TIP) raised flags for FDA reviewers, it didn't faze the agency's Anti-Infective Drugs Advisory Committee.

With science boldly taking us where we’ve never gone before, we’re exploring new worlds and stretching the boundaries of our universe. While these are exciting times for the adventurer in us, they can be discomfiting for our inner ethicist. From cloning to stem cell research to genetic testing to patent eligibility to drug pricing to compassionate use to quality-of-life issues, we face a growing number of decisions fraught with moral and ethical questions that cannot be easily answered in a lab or by a textbook. What once were merely philosophical debates about the future promise of science have become gut-wrenching...

Novartis AG hopes to show an FDA advisory committee that it can teach a new trick to an old dog to make management of Pseudomonas aeruginosa easier for cystic fibrosis (CF) patients.