Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable outcome measures for a study, accounted for significant delays in the approval of new drugs by the Food and Drug Administration ...
A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson's blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.
(Medical Xpress)—Dr. Robert Green, a medical geneticist with Brigham and Women's Hospital and Nita Farahany, professor of genome sciences and policy at Duke University, who also happens to be a lawyer have ...
Efforts to cure hepatitis C, the liver-damaging infectious disease that has for years killed more Americans than HIV/AIDS, are about to get simpler and more effective, according to new research at Johns Hopkins and elsewhere.
(HealthDay)—The U.S. Food and Drug Administration on Friday approved Mekinist for use with another drug, Tafinlar, to treat advanced melanoma that is spreading or cannot be removed by surgery.
The federal government has sent letters to states and other stakeholders across the country calling on them to encourage compounding pharmacies to register as a producer of sterile drugs in an effort to protect the public.
(HealthDay)—A sealant gel to prevent fluid leakage after cataract surgery has been approved by the U.S. Food and Drug Administration.
(HealthDay)—Concussions can't be prevented, treated or cured with dietary supplements, according to the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.
(HealthDay)—The American Academy of Family Physicians (AAFP) has expressed their support for the U.S. Food and Drug Administration's tentative determination regarding partially hydrogenated oils (PHOs) ...
(AP)—The Food and Drug Administration approved fewer first-of-a-kind drugs in 2013 compared with 2012, when new drug approvals reached a 15-year high.
French drug giant Sanofi announced Monday US health authorities had rejected its Lemtrada drug for some forms of multiple sclerosis, which is already approved in the European Union, Canada and Australia.
(HealthDay)—Tretten (coagulation factor XIII A-Subunit recombinant) has been approved by the U.S. Food and Drug Administration to treat a very rare blood clotting disorder called congenital Factor XIII A-Subunit deficiency.
(HealthDay)—A new rule to protect the nation's food supply from terrorism has been introduced by the U.S. Food and Drug Administration, the agency announced Friday.
(HealthDay)—The Axios Stent and Delivery System has been approved by the U.S. Food and Drug Administration to treat infected pancreatic cysts that won't drain on their own and could become life threatening, the FDA said ...