Donna Young

FDA Advisers to Examine KRAS Studies for Erbitux, Vectibix Labels

Dec. 16, 2008

By Donna Young

Daschle to Lead HHS, White House Health Reform Office

Dec. 15, 2008

By Donna Young

Salix Bowel Cleansing Products Get FDA Black-Box Warning

Dec. 12, 2008

By Donna Young

Pain Therapeutics, King Tumble On FDA's Remoxy Rejection

Dec. 12, 2008

By Donna Young

Shares of Pain Therapeutics Inc. plunged 21 percent Thursday after the San Mateo, Calif.-based firm said it received a complete response letter from the FDA for Remoxy, a controlled-release formulation of oxycodone. (BioWorld Today)

FDA Advisers Back New Version of Genzyme's Knee-Pain Drug

Dec. 11, 2008

By Donna Young

Targanta Shares Plunge on cSSSI Complete Response

Dec. 10, 2008

By Donna Young

Shares of Targanta Therapeutics Corp. plummeted 40 percent Tuesday after the Cambridge, Mass.-based firm said it received a complete response letter from the FDA asking for another study of oritavancin, an investigational antibiotic being developed for the treatment of complicated skin and skin structure infections (cSSSIs). (BioWorld Today)

Stupak urges Obama to go outside FDA for new chief

Dec. 9, 2008

By Donna Young

Human Genome's HCV Drug Meets Goal in Phase III Study

Dec. 9, 2008

By Donna Young

Results of a Phase III study showed that Human Genome Sciences Inc.'s Albuferon (albinterferon alfa-2b) in combination with ribavirin was noninferior to Roche AG's Pegasys (peginterferon alfa-2a) - the standard of care - in treating patients with genotypes 2 and 3 chronic hepatitis C virus (HCV), with half as many injections. (BioWorld Today)