Merck has agreed to submit all TV ads to the FDA before running them and to adhere to agency recommendations on them as part of a Vioxx-related settlement.

Shire received a warning letter from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) asking the drugmaker to halt distribution of specific professional marketing materials for its end stage renal disease treatment Fosrenol (lanthanum carbonate).

An FDA advisory panel ruled against expanded use of Cephalon's powerful pain reliever Fentora as a treatment for non-cancer patients.

Wyeth and Elan have suspended a clinical study of their jointly developed Alzheimer's vaccine ACC-001 after a patient receiving the treatment was hospitalized for nearly two weeks with skin ulcers.

FDA deadlines for new drug approvals may lead to safety issues with medicines once they make it to market, a New England Journal of Medicine study indicates.

The FDA issued an early communication advising that it is investigating a possible risk of suicidality with Merck's allergy and asthma drug Singulair.

Merck said today that the FDA has granted priority review status to the company's supplemental Biologics License Application (sBLA) for Gardasil (human papillomavirus quadrivalent) for use in women aged 27 through 45.

Hawthorn Pharmaceuticals announced the FDA approval of the company's Granisol (granisetron HCl) oral solution. Granisol is an oral solution for the prevention of nausea and vomiting associated with cancer therapy.

FDA deputy commissioner Janet Woodcock will return to the role of permanent director of the Center for Drug Evaluation and Research following a "national search" to fill the slot.

Sales reps could be effectively barred from circulating journal article reprints discussing off-label uses under FDA's draft guidance on "good reprint practices," and the agency considers the policy to be effective already, even in its draft form.