GlaxoSmithKline's (GSK) experimental drug Promacta (eltrombopag) failed to significantly lower bleeding in patients with the rare blood disorder it was designed to treat, the FDA said.

US health officials Thursday announced the launch of a new system to better monitor the side effects of marketed pharmaceuticals.

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.