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The new indication approval is for Revlimid (lenalidomide), in combination with dexamethasone, as a treatment for patients with multiple myeloma who have received at least one prior therapy.

The approval covers cefprozil for oral suspension in 125mg/5mL and 250mg/5mL dosages. Cefprozil suspension is indicated for the treatment of patients with mild to moderate infections caused by

New River has filed the investigational new drug (IND) application for NRP409, a triiodothyronine (T3) hormone, as a treatment for patients with primary hypothyroidism. The company hopes that

Ketek’s US prescribing information has been revised after discussion with the FDA to provide healthcare professionals and patients with updated information about adverse events reported in connection with

Beginning with Teva, the Israeli generics giant has received final FDA approval for its abbreviated new drug application (ANDA) to market a generic version of Pfizer’s Zoloft (sertraline)

Under an agreement announced in April 2005, SkyePharma has received $10 million to date from Mundipharma, primarily to fund the phase II clinical trials for DepoBupivacaine, an extended-release

The Committee on Medicinal Products for Human Use (CHMP)’s ruling was based on questions concerning characterization, manufacturing and control and biosimilarity that have not yet been resolved to

In the first agreement, Medivir has outlicensed its preclinical HIV protease inhibitor project and, in the second agreement, provided a license for the MIV-210 polymerase inhibitor compound for

DG051 is a novel small-molecule inhibitor of leukotriene A4 hydrolase (LTA4H), the protein made by one of the genes in the leukotriene pathway DeCode has linked to risk