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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 [...]

FDA approves expanded indication for Brilinta to include long-term use in patients with a history of heart attack

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved BRILINTA® (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI also [...]

FDA clearance given to add genital swab claim to moderate complexity Simplexa HSV 1 & 2 direct molecular test

Quest Diagnostics, the world’s leading provider of diagnostic information services, today announced that its Focus Diagnostics products business has received FDA 510(k) clearance to add the genital swab claim to its Simplexa HSV 1 & 2 Direct molecular test on the Integrated Cycler. The new labeling clearance follows FDA’s de novo 510(k) clearance and CLIA [...]

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 [...]

FDA approves Adcetris for high risk Hodkin Lymphoma patients

Seattle Genetics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. The approval is based on a phase 3 clinical trial called AETHERA [...]