3 days popular7 days popular1 month popular3 months popular

Fewer women getting minimally invasive hysterectomies since FDA guidelines

Since the Food and Drug Administration (FDA) cautioned against using a minimally invasive method to treat fibroid tumors called power morcellation, there was a nearly quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies in Michigan, a new University of Michigan study says. After the first FDA safety communication [...]

Positive Phase III results demonstrate efficacy of AVYCAZ in complicated urinary tract infections

Allergan plc. has announced positive topline results from RECAPTURE 1 and 2, the pivotal Phase III studies evaluating the antibiotic AVYCAZ™ (ceftazidime-avibactam) as a treatment for adult hospitalized patients with complicated urinary tract infections (cUTI), including pyelonephritis. AVYCAZ consists of a cephalosporin, ceftazidime, an established treatment for serious bacterial infections, and the first and only [...]

Wide-variation found in amount, quality of evidence for high-risk therapeutic medical devices receiving FDA premarket approval

Of high-risk therapeutic devices approved via the Food and Drug Administration (FDA) Premarket Approval (PMA) pathway between 2010 and 2011, there has been wide variation in both the number and quality of premarket and postmarket studies, with approximately 13 percent of initiated postmarket studies completed between 3 and 5 years after FDA approval, according to [...]

FDA approves new treatment for chronic hepatitis C genotype 3 infections

The U.S. Food and Drug Administration has approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to [...]

FDA proposes rule to collect antimicrobial sales and distribution data by animal species

The U.S. Food and Drug Administration has proposed a rule that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for [...]