Drugs and Devices

On Sept. 28, the U.S. Food and Drug Administration (FDA) approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.Read more via FDA.gov . . .

On Sept. 28, the U.S. Food and Drug Administration (FDA) launched a user-friendly dashboard for its adverse event reporting system. The new dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the . . .

On Sept. 27, the U.S. Food and Drug Administration (FDA) approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used to make diabetes treatment decisions without calibration using a “fingerstick.”

Read More via Fda.gov . . .

In children with purulent Staphylococcus aureus skin and soft tissue infection, antibiotics, in addition to incision and draining of staph-infected areas, reduces the risk of recurrent infection, according to a study in Clinical Infectious Diseases.

Read More via Academic.oup.com . . .

On Sept. 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

Read More at FDA.gov . . .

August 2017 Vol. 12 No. 8

On Sept. 1, the U.S. Food and Drug Administration (FDA) approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML) and for he treatment of patients aged 2 years and older with CD33-positive AML . . .

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection . . .

“The FDA is committed to making new safe and effective antibacterial drugs available,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides an additional treatment option for patients with cUTI, a type of serious . . .

A device that uses a pair of magnets may be a safe and simple alternative to standard methods for creating an anastomosis, according to a study in the Journal of the American College of Surgeons. The pilot study of the Magnamosis™ device included five adult patients.
Magnetic Compression Anastomosis (Magnamosis . . .