FDA Approvals, News & Updates
The US Food and Drug Administration (FDA) today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
Major depressive disorder (MDD) is a common, chronic medical illness that affects 5% to 8% of adults in the United States annually, which amounts to approximately 25 million people.1 Although MDD is treatable in most people, only 50% of patients with MDD ever receive treatment.1,2
Injectafer (Ferric Carboxymaltose Injection) Receives FDA Approval for the Treatment of Iron-Deficiency Anemia
Iron-deficiency anemia is the most common form of anemia.1 Iron plays a key role in producing hemoglobin (Hb) in red blood cells, which enables red blood cells to carry oxygen effectively to the body’s tissues.1,2 Anemia resulting from iron deficiency can cause tiredness, weakness, and shortness of breath.2 If left untreated, iron-deficiency anemia can become severe and can lead to heart problems, including a rapid or irregular heartbeat, which can subsequently lead to an enlarged heart or heart failure.2
Fetzima Extended-Release Receives FDA Approval for the Treatment of Major Depressive Disorder in Adults
Major depressive disorder (MDD), also known as clinical depression, is a chronic medical illness characterized by persistent sadness, loss of interest in normal activities, and in some cases, by physical symptoms. MDD is associated with serious emotional and biological manifestations that affect a person’s thoughts, feelings, behavior, mood, and physical health.
Simponi Aria: A New Intravenous TNF Inhibitor for the Treatment of Patients with Moderate-to-Severe Rheumatoid Arthritis
Rheumatoid arthritis (RA), a chronic inflammatory autoimmune disorder that affects the lining, or synovium, of the joints, affects 1.3 million people in the United States. In addition to causing painful swelling that may eventually lead to bone erosion and joint deformity, RA can also affect other organs of the body, including the skin, eyes, lungs, and blood vessels.
Breo Ellipta: A Fixed-Dose Combination Oral Inhaler Receives FDA Approval for Long-Term Maintenance Treatment of COPD
Chronic obstructive pulmonary disease (COPD) is a common, life-threatening disease characterized by a persistent blockage of airflow from the lungs. COPD encompasses a range of chronic obstructive lung diseases, including chronic bronchitis and emphysema.
Invokana (Canagliflozin): First-in-Class SGLT2 Inhibitor Approved for the Treatment of Type 2 Diabetes
Diabetes affects an estimated 25.8 million people in the United States—a staggering 8.3% of the population. In addition, 35% of US adults have prediabetes and are at high risk for developing diabetes. Coinciding with the aging of the US population, the prevalence of diabetes is projected to increase dramatically over the next few decades, from approximately 1 of 10 adults today to approximately 1 of 3 adults by 2050. Approximately 90% to 95% of all cases of diabetes are type 2 diabetes mellitus, and approximately 5% are type 1 diabetes mellitus.
Nesina, Kazano, and Oseni: Three Alogliptin-Based Agents Approved for the Treatment of Type 2 Diabetes
Diabetes affects an estimated 25.8 million people in the United States—a staggering 8.3% of the population. Type 2 diabetes accounts for 90% to 95% of all adult cases of diabetes. In addition, an estimated 35% of US adults aged ≥20 years have prediabetes, and the prevalence of prediabetes jumps to 50% in adults aged ≥65 years.
Tafinlar and Mekinist: Two Oral Targeted Kinase Inhibitors for the Treatment of Patients with Metastatic Melanoma and BRAF Mutations
Cutaneous melanoma, although not the most common skin cancer, is the most deadly. Based on data collected between 2003 and 2009, the 5-year survival rate for Americans with metastatic melanoma remains very low—only 16%—for all disease stages and for both sexes. The National Cancer Institute has estimated that approximately 1 in 49 people will be diagnosed with melanoma in the United States, and more than 9450 people will die of this disease in 2013.
Simbrinza (Brinzolamide/Brimonidine Tartrate) Receives FDA Approval for the Treatment of Open-Angle Glaucoma or Ocular Hypertension
Glaucoma affects an estimated 2.2 million people in the United States, and is estimated to affect as many as 3 million people by 2020.1 Its prevalence is projected to rise with the aging of the US population.2 Glaucoma has the potential to destroy retinal ganglion cells in the optic nerve, which can lead to severe vision loss and blindness.1 In fact, glaucoma is a leading cause of blindness in the United States, accounting for 9% to 12% of all cases of blindness.3
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Results 51 - 60 of 63
Results 51 - 60 of 63