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According to Janet Woodcock, MD and director of FDA’s Center for Drug Evaluation and Research, the agency is focused on the drugs used by Americans continuing to meet “strict quality standards.”

The educational sessions are available live and via simulcast.

The contrast agent is newly indicated to opacify the left ventricular chamber, and to improve the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms.

The approval was based on a phase 3 EDITION JUNIOR trial evaluating children and adolescents, aged 6 to 17 years, living with type 1 diabetes.

Managing elevated cholesterol is one of the the key elements to decreasing negative outcomes in atherosclerotic cardiovascular disease.

Consulting with some pharmacist moms and colleagues, these are the top tips for how they make the holidays more of a celebration and less of a logistical nightmare.

A patient at age 65 with high blood pressure could extend their life by more than a year with intensive treatment focused on a target systolic blood pressure of less than 120 mm Hg.

Under a new international collaboration, the FDA has granted supplemental approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia.

The Clinical Performance and Quality Measures included 6 performance measures, 6 process quality measures, and a new category of 10 structural quality measures for adults with high blood pressure.

Top news of the day from across the health care landscape.

Top news of the day from across the health care landscape.

Why is this woman in opioid withdrawal despite high dose methadone administration?

A newly-developed machine learning system may help act as an alert system for potential adverse effects from drug-drug interactions.

Cefiderocol (Fetroja, Shionogi) is indicated for adults with complicated urinary tract infections, including kidney infections caused by Gram-negative pathogens, who have limited or no alternative treatment options.

According to the affiliation agreement, the Institute for Safe Medication Practices will be an ECRI Institute subsidiary when the transaction closes in January, 2020.

Centers for Disease Control and Prevention warns the time for action is now in the "post-antibiotic era."

Receiving a flu shot before a heart bypass surgery can stop inflammation throughout the body and possibly lead to a healthier recovery, according to a preliminary study presented at the American Heart Association’s Scientific Sessions in Philadelphia, Pennsylvania.

With vincristine in short supply, Teva will resume production of the chemotherapy agent following its previous decision to remove the product from the market.

With expanding pharmacy practice, it is time to explore conflict management, and its necessity in this current climate.

One health care organization has taken their flu vaccination efforts to the next level, by vaccinating the majority of its 12,000 employees, during a 1-day event called #HitMeWithYourFluShot.

With this approval, luspatercept-aamt (Reblozyl, Celgene) is the first FDA-approved erythroid maturation agent for anemia in beta thalassemia

Rituximab-abbs (Truxima, Teva and Celltrion), has been launched in the United States with a full oncology label for non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Pegfilgrastim-bmez (Ziextenzo, Sandoz), a biosimilar to pegfilgrastim (Neulasta), is indicated to decrease the incidence of febrile neutropenia, a serious adverse effect of chemotherapy.

Omeprazole magnesium, amoxicillin, and rifabutin (Talicia, RedHill Biopharma) is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

Top news of the day from across the health care landscape.

Texas oncologist Stephen Hahn, MD, is expected to receive the Trump administration’s nomination for the role of FDA Commissioner, a move that had been anticipated by federal insiders.

SunGen Pharma, the specialty pharmaceutical company, has received its eighth ANDA approval from the FDA.

Officials from the FDA have allowed ObsEva to begin enrolling patients in IMPLANT 3, the U.S. pivotal Phase 3 clinical trial in nolasiban in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF).

The FDA Drug Shortages Task Force addressed the root causes of drug shortages and proposed potential solutions.

The injection’s active ingredient, 17α hydroxyprogesterone caproate (also known as 17P), is currently the only approved treatment for pregnant women who have had a prior spontaneous preterm birth.