FDA News

FDA Approves Tecfidera for Treatment of Relapsing MS

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). “No drug provides a cure for multiple sclerosis, so it is important to have a… Read More

Stivarga Approved for Some Stromal Tumors After Use of First-Line Therapies

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,… Read More

Ofirmev Injection Available on VA Formulary For Relief of Mild/Moderate Pain

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. .Ofirmev is the first non-narcotic, non-NSAID, intravenous analgesic available… Read More

Kadcyla Approved for Treatment of HER2-positive Metastatic Breast Cancers

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. Kadcyla is the fourth medicine… Read More

FDA Looking to Impact Preventable Medication Harm

SILVER SPRING, MD—“Patient safety is the primary responsibility of everyone who is involved in the healthcare system.” That is the philosophy that underlies FDA’s Safe Use Initiative and what Janet Woodcock, MD, director of the Center for Drug Evaluation and… Read More

Gaps in Women’s Health Research Remain Despite Progress

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. A concerted push to boost research on women’s health has had significant impacts… Read More

FDA Starts Early MDUFA Reauthorization Talks

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.… Read More

FDA Adverse Event Reporting, Analysis Being Reviewed

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. “We’ve seen a lot of… Read More

FDA Recommitting to Regulatory Science

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… Read More

Dr. Margaret Hamburg Is New FDA Commissioner

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.… Read More