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.

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.

The UK's drugs regulatory agency said it would not prosecute GlaxoSmithKline (GSK) for allegedly withholding clinical trials data related to its antidepressant Seroxat (paroxetine), sold in the US under the brand name Paxil.

The FDA approved AstraZeneca's Nexium (esomeprazole magnesium) for short-term use in children ages one -11 years for the treatment of gastroesophageal reflux disease (GERD).

Friday's approval of Genentech's Avastin to treat breast cancer caught many on Wall Street off guard and could represent a change in the way the agency measures the effectiveness of cancer medicines.

The FDA examined the wrong factory when assessing the safety of a Chinese-made ingredient used to make Baxter International's blood thinner Heparin. The drug has been recently linked to four deaths and hundreds of reports of allergic reactions.

The FDA granted approval to Abbott's NDA for Simcor, a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin, the generic version of Merck's Zocor.

The FDA has issued draft guidance on "Good reprint practices" for distribution of journal articles involving unapproved uses of FDA-approved drugs and medical devices.

AstraZeneca submitted applications in the European Union for once-daily Seroquel XR (quetiapine fumarate), seeking approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

FDA issued an "early communication" advising that it is looking into adverse reactions to Botox and Botox Cosmetic that have been blamed for hospitalizations and even deaths -- mostly in children treated for cerebral palsy-associated limb spasticity, an off-label usage.