Things heat up in Washington as FDA is called to task for a controversial contracts deal with a local public relations firm. Both the Senate and the House are looking for answers, and the feds no longer have a PR firm to run damage control.

Colorful and cheerful aren’t always a good thing; an illustrated brochure for Amgen’s Sensipar gets canned by FDA for too thin a listing of side effects and adverse reaction data.

Wyeth v. Levine was argued before the US Supreme Court on Monday. With the justices asking aggressive questions of both sides, the verdict remains very much in doubt. All eyes are on Washington.

A new study finds that side-effect reports are on the rise, with Chantix and heparin topping the list. Are popular drugs getting a bad rap because they're in the headlines? Or are people just reporting more side effects?

Shire received a warning letter from FDA citing failure to provide warnings in non-traditional consumer ads. Is it time to look at better regulations for new media? Worse yet, is FDA watching YouTube?

Lilly's coronary drug still hasn't been approved. FDA is mum on what?s taking so long, and analysts are left pondering the status of the medication.

Just a few weeks from the start of the mammoth Wyeth v. Levine Supreme Court hearing, a small state case hammered home the fact that generic drug manufacturers can't expect preemption to save them just because FDA approved the label.

Merck got good news on Monday, as its HPV vaccine Gardasil was given the green light to be used as a preventive for vaginal and vulvar cancer.

FDA launches new quarterly posting of drugs being assessed for possible safety problems. Oh, yes, and the agency recommends that patients keep taking drugs that make the list.