Pharmaceutical manufacturer Sanofi has announced that the US Food and Drug Administration (FGA) has granted Breakthrough Therapy Designation to Cemiplimab (REGN2810) as a treatment for adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable...

A combination therapy used to reduce the chances of HIV infection in adult patients is safe for adolescents, a new study by the National Institutes of Health network suggests. Truvada (tenofovir, emtricitabine) is a single pill combination drug currently approved as a pre-exposure prophylaxis...

Patients whose healthcare providers adopt a collaborative communication style are more likely to take their high blood pressure medication correctly, according to a recent study. Research published in the American Heart Association's (AHA) journal Circulation: Quality and Outcomes suggests patients...

The first treatment for Chagas disease in the United States has been approved by the US Food and Drug Administration (FDA). Benznidazole was granted accelerated approval for use in children between the ages of two and 12 years old. The drug also received priority review and orphan product...

Vabomere (meropenem and vaborbactam), an injection for treating adult patients with complicated urinary tract infections (cUTIs) will be available in the United States. by the end of 2017. Rempex Pharmaceuticals was granted approval for the antibiotic by the US Food and Drug Administration (FDA),...

The US Food and Drug Administration (FDA) has issued a statement clarifying its position on Keytruda (pembrolizumab) after scientists monitoring studies of the drug found an excess of deaths among patients given the drug in combination with certain other medicines.  Currently, Keytruda is...

Pfizer's acute myeloid leukemia (AML) medicine Mylotarg (gemtuzumab, ozogamicin) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA). The drug is indicated for the treatment of adults with newly diagnosed AML whose tumors express the CD33 antigen (CD33-positive...

Everyone needs a vacation, but when traveling overseas it is important to make preparations to ensure holidays are not cut short by illness and sickness. Some simple steps include: packing prescription medications, and the prescriptions themselves; ensuring all vaccines are up to date; and checking...

Many medications are available for treating type 2 diabetes, but intensive lifestyle management could hold the key to controlling blood sugar levels, according to a recent clinical trial. The results of the study conducted in Denmark suggest adding "intensive" lifestyle management to traditional...

Half the respondents to a recent survey are aware of what pneumococcal disease is, but less than one-third were vaccinated against the condition. The poll, conducted by the Asthma and Allergy Foundation of America (AAFA), revealed a significant proportion of at-risk respondents were not immunized...

Patients with gout will soon have a new treatment option available in pharmacies following the US Food and Drug Administration's (FDA) approval of Duzallo (allopurinol, lesinurad). The once-daily oral medicine was developed by Ironwood Pharmaceuticals and is indicated for the treatment of...

More than six out of ten (61%) Americans get a flu vaccine each year or plan to get one this year, two percentage points higher than last year, according to a recent survey conducted on behalf of CVS Health. Seniors aged 65 and above were more likely to get immunization than younger people, with 76...

The US Food and Drug Administration (FDA) has announced a meeting with the Pediatric Advisory Committee to evaluate the use of prescription medication containing opioids when treating coughs in children. A statement by FDA Commissioner Scott Gottlieb, MD, highlighted the potential risks of these...

Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) have a new targeted treatment option, following the US Food and Drug Administration's (FDA) approval of Besponsa (inotuzumab ozogamicin). The drug, developed by Pfizer, was granted Priority Review,...

A new treatment option for patients with amyotrophic lateral sclerosis (ALS) is now available in US pharmacies for the first time in 22 years. Radicava (edavarone), developed and manufactured by Mitsubishi Tanabe Pharma America, was approved by the US Food and Drug Administration (FDA) in May 2017....

Defects in dropper markings have led Amneal Pharmaceuticals to announce a voluntary recall of 13 lots of Lorazepam Oral Concentrate USP 2mg/ml. A consumer report drew the generic drug manufacturer's attention to the issue with the dosing dropper, which is supplied to Amneal by a third party. Some...

All liquid products manufactured by PharmaTech have been recalled due to the risk of Burkholderia cepacia contamination. The US Food and Drug Administration (FDA) announced the voluntary recall of liquids distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories, including various...

The number of prescriptions filled in the United States has risen from 2.4 billion 1997 to 4.4 billion in 2016, according to figures from Quintiles IMS. With a recent Consumer Reports survey showing more than half of Americans regularly take prescription medication, the need for organized and safe...

Vyxeos (daunorubicin and cytarabine) has been approved by the US Food and Drug Administration (FDA). It is the first treatment approved for patients with certain types of high-risk acute myeloid leukemia (AML). The drug, developed by Jazz Pharmaceuticals, is a fixed combination of two chemotherapy...

The US Food and Drug Administration (FDA) has released its latest guidelines for the development of generic drugs and has requested feedback and comments on its guidance. Recently, the FDA has taken steps to increase the number of generic drugs available in the US and is on track to make a record...