FDA Approves ACTOplus Met(R) XR (pioglitazone HCl And Metformin HCl Extended-release) Tablets For The Treatment Of ... (Medical News Today)
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved an extended-release version of the combination medication ACTOplus met(R) (pioglitazone HCl and metformin HCl) as an adjunct to diet and exercise for the treatment of type 2 diabetes.

GSK Awaits FDA Decision On Cervarix HPV Vaccine, Hopes To Compete With Merck's Gardasil (Medical News Today)
FDA is expected to make a decision in the next several months over whether to approve GlaxoSmithKline's human papillomavirus vaccine Cervarix for the U.S. market, the AP/Philadelphia Inquirer reports. If approved, Cervarix is expected to face a tough fight to take away market share from Merck's Gardasil, an HPV vaccine that has been available in the U.S.

FDA Calendar Updates for AZN, MIPI, MELA, IMGN (PR.com)
While there are still significant upside catalysts for the stock starting with the finalization of the pixantrone NDA filing in June and priority review ruling by the FDA, the risk/reward is drastically different at current levels compared to a earlier reports. [PR.com - May 12, 2009]