The US Food and Drug Administration has approved a new indication for the Actelion Pharmaceutical's drug Tracleer (bosentan). The medication may now be used to treat pediatric patients aged three and over who suffer from idiopathic or congenital pulmonary arterial hypertension...

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),...

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...

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...

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....

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...

The US Food and Drug Administration (FDA) approved the hepatitis C virus (HCV) treatment Mavyret (glecaprevir, pibrentasvir), granting biopharmaceutical firm AbbVie Breakthrough Therapy Designation and Priority Review for the treatment of GT1 HCV patients not cured with prior direct-acting...

Haegarda, the first subcutaneous preventative treatment for patients with hereditary angioedema (HAE), is now available in American pharmacies. The drug, developed by pharmaceutical giant CSL Behring, was approved for routine prophylaxis to prevent HAE attacks in adults and adolescents by the US...

The US Food and Drug Administration (FDA) has granted approval for a new self-injectable formulation of Benlysta (belimumab) developed by GlaxoSmithKline (GSK). The new product was approved for treating adult patients with active autoantibody-positive systemic lupus erythematosus (SLE). Vlad...

Patients with HER2 breast cancer will have a new treatment option available later this year, following the US Food and Drug Administration's (FDA) approval of the first extended adjuvant treatment for the condition. Nerlynx (neratinib), a kinase inhibitor from Puma Biotechnology, was granted FDA...

Pharmaceutical giant Merck has been granted tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL by the US Food and Drug Administration.  The follow-on biologic basal insulin comes in a pre-filled dosing device and will be used to treat patients with type 2...

A new hepatitis C virus (HCV) treatment is expected to appear in pharmacies soon following US Food and Drug Administration's (FDA) decision to approve Vosevi, an HCV treatment developed by Gilead Sciences, Inc. The drug was cleared to treat adults with chronic HCV genotypes 1-6 with no cirrhosis,...

Patients with sickle cell disease will soon have access to a new treatment following the US Food and Drug Administration's (FDA) approval of Endari (L-glutamine oral powder). The drug was cleared for use in reducing some of the serious complications often experienced by patients aged five years of...

The US Food and Drug Administration (FDA) has unveiled a 90-day plan to address the backlog of around 200 orphan drug designation requests that have been pending for more than 120 days. The regulatory body aims to complete reviews of all requests in this category by September 21st 2017 and plans to...

A new once-daily medication to treat patients with attention deficit and hyperactivity disorder (ADHD) aged 13 and above has been approved by the US Food and Drug Administration (FDA). Shire first filed an application to market the drug in US pharmacies in 2006, but was required to conduct...

A new treatment for adults with acute bacterial skin and skin-structure infections has been granted approval by the US Food and Drug Administration (FDA). Baxdela (delafloxacin) is available as an intravenous formulation and in oral form and was developed by Melinta Therapeutics. It is a...