The Centers for Disease Control and Prevention (CDC) now formally recommends Shingrix (zoster vaccine recombinant, adjuvanted) as the vaccine of choice against shingles. It is only the second shingles vaccine to gain US Food and Drug Administration approval; the first was Merck’s drug...

The US Food and Drug Administration (FDA) has approved the radiopharmaceutical Lutathera (lutetium Lu 177 dotatate) as a treatment for certain cancers of the pancreas and gastrointestinal tract. The drug, developed by pharmaceutical group Advanced Accelerator Applications, is the first radioactive...

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have turned their attention to companies illegally marketing products to help with opioid withdrawal and addiction. The agencies sent letters to the marketers and distributors of the products with warnings about their...

In the latest step taken by the US Food and Drug Administration (FDA) to address the nation's opioid abuse epidemic, the agency has changed the indication of cough medicines containing opioids to exclude all pediatric patients.  Following the latest safety labeling changes, opioid cough and...

Lynparza (olaparib tablets) is the first poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with breast cancer whose tumors have a specific inherited genetic mutation. Lynparza is already approved in the United States as a treatment for a number of other cancers,...

Diabetes is one of the most prevalent conditions in the United States, with figures from the Centers for Disease Control and Prevention suggesting almost one in ten people live with the condition, the equivalent to 30 million people across the country.  The majority of cases - nine out of ten...

Over the course of 2017, the number of approvals granted by the US Food and Drug Administration (FDA) reached a 21-year high. More than 1,000 generic drugs were approved by the agency, according to FDA Commissioner Scott Gottlieb, MD, while first-time generic drug approvals numbered 74. Novel drug...

Last month, the US Food and Drug Administration (FDA) announced plans to speed up the review process for generic drug applications, with the goal of providing patients with more generic medicine options. Generic drugs account for nine out of ten prescriptions in the United States, according to the...

Juluca (dolutegravir and rilpivirine), the first two-drug regimen for certain patients with HIV is now available in pharmacies across the United States. In November 2017, Viiv Healthcare, owned by pharmaceutical giant GlaxoSmithKline, gained US Food and Drug Administration (FDA) approval for...

The US Food and Drug Administration (FDA) has announced new measures to streamline its generic drug application review process. The agency is working to reduce the number of review cycles required for generic applications before they can be approved for use in the United States, FDA Commissioner...

Health insurance customers generally enjoy two main benefits with regards to prescription drugs. Firstly, insurance policies often entitle holders to cheaper medication. Second, a low co-pay is usually set, although this can vary between policies and between drugs. When you require a prescription,...

The US Food and Drug Administration (FDA) has announced its intention to introduce a new “risk-based enforcement approach” to protect consumers from unproven homeopathic products that could be potentially harmful to their health.  According to the Center for Drug Evaluation and...

Pharmacies in the United States will soon stock two more medications for treating type 2 diabetes after pharmaceutical giants Merck and Pfizer had a pair of products approved by the US Food and Drug Administration (FDA). Steglujan (ertugliflozin and sitagliptin) and Steglatro (ertugliflozin) were...

Giapreza (angiotensin II) injection is now approved for treatment of dangerously low blood pressure in adults with septic or other forms of distributive shock. The intravenous infusion gained US Food and Drug Administration (FDA) approval following a clinical trial of 321 patients with shock and a...

Sanofi’s Admelog (insulin lispro injection) is the first short-acting “follow-on” insulin product for diabetes treatment to gain approval from the US Food and Drug Administration (FDA). The rapid-acting insulin is similar to Humalog and is indicated to improve blood sugar control...

A cheaper generic version of erectile dysfunction drug Viagra (sildenafil citrate) is now available in the United States. Sildenafil is a PDE-5 inhibitor, which works by relaxing the blood vessels and facilitating easier blood flow to the penis.  The branded drug Viagra is manufactured by...

Aurobindo Pharma has received US Food and Drug Administration approval for its quetiapine fumarate extended-release tablets (50mg, 150mg, 200mg, 300mg, and 400mg). The medication is a bioequivalent of the AstraZeneca drug Seroquel XR and is therapeutically equivalent to this...

The US Food and Drug Administration (FDA) has approved Sunovion’s Lonhala Magnair (glycopyrrolate), making it the first nebulized long-acting muscarinic antagonist (LAMA) treatment in the United States for patients with chronic obstructive pulmonary disease (COPD). It is expected to appear in...

The US Food and Drug Administration (FDA) has approved the Auvi-Q (epinephrine injection USP) 0.1mg auto-injector as a treatment for life-threatening allergic reactions in children and infants. The Kaléo product was granted Priority Review by the FDA and is expected to be available in...

The US Food and Drug Administration has granted approval to Sublocade (buprenorphine extended release) for the treatment of patients with moderate to severe opioid use disorder. Shaun Thaxter, chief executive officer of Indivior, described the approval as an “important step forward for...