FDA Approvals, News & Updates

Allergic diseases, including asthma, represent the fifth most common chronic diseases in individuals of all ages, and the third most common chronic diseases in children.
On April 11, 2016, the FDA approved venetoclax (Venclexta), the first-in-class BCL-2 inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) and 17p deletion who received ≥1 previous therapies.
Inflectra is approved for several indications, similar to its originator, including severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis.
On March 30, 2016, the US Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for the treatment of children and adult patients with hepatic veno-occlusive disease plus kidney or lung abnormalities after hematopoietic stem-cell transplantation. This is the first drug to be approved by the FDA for patients with severe hepatic veno-occlusive disease.
On March 11, 2016, the US Food and Drug Administration (FDA) approved an expanded indication for crizotinib (Xalkori; Pfizer) for the treatment of patients with metastatic non−small-cell lung cancer (NSCLC) that harbors the ROS-1 genetic mutation. Crizotinib is the first and only FDA-approved treatment for this patient population; the drug blocks ROS-1 protein activity in tumors, with the potential to prevent NSCLC tumors from spreading.
On March 4, 2016, the US Food and Drug Administration (FDA) approved a new type of coagulation factor IX (recombinant), albumin fusion protein (Idelvion; CSL Behring), for use in children and adults with hemophilia B. Used to replace a naturally occurring clotting factor functionally deficient or defective in these patients, this is the first coagulation factor-albumin fusion protein drug to be approved by the FDA.
American Health & Drug Benefits publishes a Payers' Guide to New FDA Approvals annually with the goal of providing payers and other healthcare stakeholders a comprehensive review of pharmaceuticals that were newly approved or that received important new indications by the US Food and Drug Administration (FDA) in the previous year.
The year 2015 was interesting for new drug approvals. As was the case in the recent past, these approvals were dominated by specialty drugs, many of which were first-in-class therapies.
  1. New Pharmaceuticals: New Molecular Entities and New Biologic License Applications
  2. New Combinations and New Indications
  3. New Dosage Forms and New Formulations
  4. New Biosimilars, Vaccines, Viral Therapies, and Blood Products
The year 2015 brought important advances in the treatment of multiple myeloma. Most impressive was the US Food and Drug Administration (FDA) approval of 4 novel agents—panobinostat (Farydak), daratumumab (Darzalex), elotuzumab (Empliciti), and ixazomib (Ninlaro)—as well as new indications for 3 drugs already on the market—lenalidomide (Revlimid), carfilzomib (Kyprolis), and pomalidomide (Pomalyst).
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