Fierce Healthcare

Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status

LEXINGTON, Mass., June 4 /PRNewswire/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the ...
FierceBiotech

Indevus Pharmaceuticals Expects FDA to Request Additional Safety Study of NEBIDO Prior to Approval

LEXINGTON, Mass., June 4 -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the NDA ...
FierceBiotech

Indevus and FDA Agree on Path Forward for NEBIDO(R)

LEXINGTON, Mass., Sept. 26 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that it has reached agreement with the U.S. Food and ...
BioWorld

Nebido Approval Delayed Two Years on FDA Safety Concerns

Shares of Indevus Pharmaceuticals Inc. plunged nearly 70 percent after the company reported at least a two-year setback for Nebido, its three-month formulation of testosterone, for male hypogonadism ...
Reuters

Indevus testosterone drug hits safety snag, shrs crash

BANGALORE, June 4 (Reuters) - Indevus Pharmaceuticals Inc's injectable testosterone drug's approval may be delayed by two years, as U.S. health regulators are expected to ask for more safety data, ...