FDA Approvals, News & Updates

Chronic lymphocytic leukemia (CLL) is a cancer of B-cell lymphocytes and is the most common type of leukemia in adults. More than 20,000 Americans were diagnosed with CLL in 2018.
Lung and bronchus cancer, the second most common form of cancer, accounts for 13.5% of all new cancer cases in the United States.
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), also known as carcinoids and islet-­cell tumors, are tumors of the neuroendocrine cells that occur in the gastrointestinal (GI) tract.
Lung and bronchus cancer is the second most common form of cancer in the United States. In 2018, lung cancer was newly diagnosed in 234,030 individuals, representing 13.5% of all new cancer cases.
Acute myeloid leukemia (AML) is a rare but deadly hematologic cancer. In 2018, approximately 19,500 new cases of AML were diagnosed, and more than 10,600 people died from the disease in the United States.
Prostate cancer is the third most common type of cancer in the United States, after breast cancer and lung cancer. In 2018 alone, 164,690 individuals were diagnosed with prostate cancer, accounting for nearly 10% of all new cancer cases, and 29,430 deaths were attributed to the disease.
  • Another Approval for Keytruda and An Easing of Pregnancy Restrictions for Women Taking Soltamox
  • FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox
American Health & Drug Benefits is pleased to bring you the Tenth Annual Payers’ Guide to New FDA Approvals. As has now become a tradition of this publication, the goal of this Guide is to offer payers, providers, Pharmacy & Therapeutics committees, and other healthcare stakeholders an overview of the novel pharmaceuticals approved by the US Food and Drug Administration (FDA) in 2018.
Before we discuss the new indications for oncology therapies approved in 2018, a word about the novel drugs entering the market is in order, considering the new record set last year in drug approvals in the United States.
New Molecular Entities and New Biologic License Applications and New Biosimilars Approved in 2018
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