WESTON, MA - The U.S. Food and Drug Administration has approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).

WAYNE, NJ - Tthe U.S. Food and Drug Administration (FDA) has approved Bayer's Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate, according to Bayer HealthCare and Onyx Pharmaceuticals, Inc.

SAN DIEGO - Cadence Pharmaceuticals, Inc. announced that Ofirmev (acetaminophen) injection has been made available on the VA National Formulary (VANF) and must be available for prescription at all VA facilities.

SAN FRANCISCO - The FDA has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy.

WASHINGTON, DC—Research into women’s healthcare has improved over the last 20 years, but still lags in several key areas, according to an IoM report released last month.

HYATTSVILLE, MD—Even though the Medical Device User Fee Act is not scheduled to expire until September 2012, FDA is already beginning the process of soliciting comments on how the act has worked to date, and how it might be improved.

ROCKVILLE, MD—“One of the things the public has problems dealing with is uncertainty and building science around that uncertainty,” declared Jesse Goodman, MD, FDA’s science chief, at a recent meeting of the FDA Science Board.

BETHESDA, MD—Efforts in basic science at FDA have, in recent years, been “underappreciated, under resourced, and underfunded,” even though they are an essential component of the agency, FDA Commissioner Margaret Hamburg, MD told the members of FDA’s Science Board at a recent meeting.

WASHINGTON, D.C.—The Senate confirmed Margaret Hamburg, MD, to lead the Food and Drug Administration last month. The unanimous confirmation came as no surprise considering the ease of her confirmation hearing and her backing by both Democrat and Republican Senate leaders.