One of the nation's leading medical researchers joined the Food and Drug Administration on Monday, taking on the agency's No. 2 leadership job at a critical juncture for prescription drugs, medical devices and tobacco products.
Shares of Pacira Pharmaceuticals tumbled Monday after the company said regulators refused to...
Bipartisan Act would preserve FDA user fees from sequestration.
Federal prosecutors have indicted a New Jersey compounding pharmacy and top company officials on...
Studies of baby animals have long suggested that going under anesthesia can have some harmful effects on a developing brain. Now some scientists want to find out whether those same drugs may pose subtle risks for human babies and toddlers.
Legislation that would give terminally ill patients in Oklahoma access to experimental medications that are not yet on pharmacy shelves could restore a sense of dignity to those who are dying, the measure's author said Wednesday.
Federal health officials have approved a new antibiotic combination to treat several hard-to-treat infections. The drug contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria.
A recent report found that recalls of products overseen by the U.S. Food and Drug Administration fell during the final quarter of 2014 but the number of affected units increased.
Until recently, there was no vaccine available in the US to help protect against meningococcal group B, one of the most prevalent types of meningococcal meningitis in the US.
Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the company’s hydrocodone bitartrate extended-release (ER) tablets formulated with Teva’s proprietary abuse deterrence technology (CEP-33237).
GSK voluntary recalled Alli last March after finding some packages in stores didn't contain real alli, indicating tampering after shipment. The Food and Drug Administration is still investigating.
A consumer safety group is calling on the U.S Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.
The U.S. Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow.
Three weeks after ordering four major retailers to pull store-brand herbal supplements off their shelves following DNA tests that found little or none of the listed herbs, New York's attorney general is targeting manufacturers of the popular products.
An 18-year-old student is struggling to survive after he was infected by a "superbug" outbreak tied to contaminated medical instruments at a Los Angeles hospital, his attorney said.
Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology.
The U.S. Food and Drug Administration recently issued a slew of proposed guidelines regarding drug compounding and repackaging under the Drug Quality and Security Act.
Celgene Corporation has announced that the FDA has expanded the existing indication for REVLIMID® (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM).
Hundreds of products are being pulled from store shelves after traces of peanut were found in cumin spice — a life-threatening danger to some people with peanut allergies.
FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced MelanomaFebruary 19, 2015 8:18 am | News | Comments
Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf ® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma
Could misuse of the popular beauty treatment have impact on your health?
Eisai has announced that the FDA approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).
The makers of a twice-rejected pill designed to boost female libido are resubmitting their drug to federal health regulators, following a recent lobbying blitz by politicians, women's groups and consumer advocates aimed at pushing it onto the market.
The FDA has cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation.
The U.S. Food and Drug Administration has filed a draft of its proposed industry guidelines for developing drugs to combat alcoholism, particularly regarding potential clinical trials.
Hospira has announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials.
FDA Approves Genentech’s Lucentis® for Treatment of Diabetic Retinopathy in People With Diabetic Macular EdemaFebruary 9, 2015 7:12 am | News | Comments
Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.
Margaret Hamburg told employees of the FDA in an email that the agency's chief scientist, Stephen Ostroff, will serve as acting commissioner. She is among the longest-serving commissioners to head the agency and helped oversee the creation of a new food safety system, reforms in how drugs are reviewed and new tobacco regulations.
The U.S. Food and Drug Administration has authorized using a hyperactivity drug for treatment of binge eating. The FDA originally approved Vyvanse in 2007 to treat attention deficit hyperactivity disorder in patients ages 6 and older.
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