Cancer medication Blincyto (blinatumomab) has received accelerated approval as a treatment to reduce the risk of relapse in certain patients with B-cell precursor acute lymphoblastic leukemia (ALL). Under the latest US Food and Drug Administration (FDA) approval, Blincyto is indicated for adults...

The US Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The Sun Pharma drug was granted approval following two Phase 3 clinical trials featuring 926...

In an exciting breakthrough for patients with diabetes, the US Food and Drug Administration (FDA) has authorized the marketing of the Dexcom G6 integrated continuous glucose monitoring system (iCGM). The latest version of the continuous glucose monitoring system is indicated for use by patients...

The US Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) as a treatment for certain adult patients with classical Hodgkin lymphoma (cHL). Under the latest approval, the Seattle Genetics drug is indicated for use in combination with chemotherapy as a treatment for...

A new treatment option is available for patients with multi-drug resistant (MDR) HIV following the US Food and Drug Administration’s (FDA) approval of Trogarzo (ibalizumab-uiyk). The medication, developed by TaiMed Biologics USA Corp, is a new form of antiretroviral medication indicated for...

Last year was a record-breaking year for generic drug approvals in the United States. The US Food and Drug Administration (FDA) approved 1,027 generic drugs, 843 of which were full approvals, with tentative approvals making up the remainder. Tentative approvals are generic drugs considered ready...

The US Food and Drug Administration (FDA) has expanded the approval of Imfinzi (durvalumab) to provide a therapy to slow the progression of cancer in certain patients with non-small cell lung cancer (NSCLC). AstraZeneca first gained accelerated FDA approval for Imfinzi in May 2017. Imfinzi is an...

A nationwide voluntary recall of the seizure medication divalproex sodium delayed-release tablets has been issued by the manufacturer Unichem Pharmaceuticals. The recall was issued earlier this month as a precautionary measure due to the possibility the product may be contaminated with traces of...

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...

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,...

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...

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...