FDA Approvals, News & Updates
Idhifa (Enasidenib), First-in-Class IDH2 Inhibitor, Approved for Relapsed Acute Myeloid Leukemia with IDH2 Mutation
Acute myeloid leukemia (AML) is a rapidly progressing cancer that develops in the myeloid cells of the bone marrow and travels into the blood, sometimes spreading to other parts of the body, including the lymph nodes, liver, brain, spinal cord, spleen, and testicles.
Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer
Urothelial carcinoma is the primary subtype of bladder cancer, which is the sixth most common cancer in the United States. More than 79,000 cases of bladder cancer were estimated to be diagnosed, and nearly 17,000 people to die from this disease in 2017.
Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer
Breast cancer is one of the most common cancer diagnoses in the United States. The National Cancer Institute estimates that 252,710 American women will be diagnosed with breast cancer and 40,610 will die from the disease in 2017.
Breast cancer is the most common type of cancer in women, representing 15% of all new cancer cases in the United States. In 2017, 252,710 new cases of breast cancer were estimated to be diagnosed, and more than 40,600 women to die from the disease.
Shingrix (Zoster Vaccine Recombinant) a New Vaccine Approved for Herpes Zoster Prevention in Older Adults
Herpes zoster, also known as shingles, is characterized by a painful itchy rash on one side of the face or body that lasts for 2 to 4 weeks. It is caused by the varicella zoster virus, the same virus that causes chickenpox. An estimated 1 million people have herpes zoster infection annually in the United States, and 1 of 3 Americans will have the infection in their lifetime.
Psoriasis, a chronic autoimmune disease characterized by thick, inflamed patches of skin, affects approximately 7.5 million people in the United States. Plaque psoriasis is the most common form of psoriasis, affecting 80% to 90% of patients with the disease.
Simponi Aria (Golimumab), the Only Fully Human Anti–TNF-α Infused Therapy, Now Approved for Active Psoriatic Arthritis and for Active Ankylosing Spondylitis
Ankylosing spondylitis, a form of spondyloarthritis, is an inflammatory disease that often affects the sacroiliac, the spine and lower back, the entheses (where tendons and ligaments connect to bone), the cartilage between the ribs and breastbone, and the hip and shoulder joints.
Tremfya (Guselkumab), First-in-Class IL-23 Blocker, Approved for the Treatment of Patients with Moderate-to-Severe Plaque Psoriasis
Severe cases of psoriasis can lead to disfigurement and disability. Furthermore, patients with psoriasis are at increased risk for psoriatic arthritis, cardiovascular disease, stroke, hypertension, type 2 diabetes, metabolic syndrome, eye disorders, and obesity, as well as for other autoimmune diseases.
Vyxeos (Daunorubicin and Cytarabine) Liposomal Combination First Treatment Approved for Patients with High-Risk Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a rare but deadly cancer. Approximately 21,400 new cases of AML were diagnosed in 2017 in the United States, and nearly 10,600 people died from the disease. Approximately 60% to 70% of adults with AML respond to initial treatment with cytotoxic chemotherapy.
Xermelo (Telotristat Ethyl), First-in-Class Tryptophan Hydroxylase Inhibitor, Approved for Carcinoid Syndrome Diarrhea
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Results 21 - 30 of 148
Results 21 - 30 of 148