In the News
At the end of November, the FDA approved elotuzumab (Empliciti) for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received 1 to 3 previous medications. Elotuzumab is the second FDA-approved monoclonal antibody for patients with multiple myeloma; the first agent (daratumumab) was approved earlier in the month.
Cosentyx (Secukinumab): First IL-17A Antagonist Receives FDA Approval for Moderate-to-Severe Plaque Psoriasis
Ixazomib (Ninlaro) has been approved for use in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 previous therapy. This is the first oral proteasome inhibitor to be approved for this patient population.
Keytruda (Pembrolizumab) First PD-1 Inhibitor Approved for the Treatment of Patients with Metastatic Non–Small-Cell Lung Cancer Expressing PD-L1
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.
- First HDAC Inhibitor, Panobinostat, Approved for the Treatment of Patients with Multiple Myeloma
- Palbociclib Approved for Metastatic Breast Cancer in Postmenopausal Women
- FDA Expedites Approval of Lenvatinib for Refractory Differentiated Thyroid Cancer
- Lenalidomide plus Dexamethasone Receives Expanded Indication for Patients with Newly Diagnosed Myeloma
- Nivolumab First Immunotherapy to Get FDA Approval for Metastatic Lung Cancer
A Payers’ Guide to New FDA Approvals is published annually by American Health & Drug Benefits to offer payers and other healthcare stakeholders a detailed analysis of new drugs approved by the US Food and Drug Administration (FDA) in the previous year, as well as a preview of some of the key trends in the 2015 drug pipeline.
On January 8, 2014, the US Food and Drug Administration (FDA) approved the use of dabrafenib (Tafinlar; GlaxoSmithKline) plus trametinib (Mekinist; GlaxoSmithKline) as a new combination therapy for the treatment of patients with advanced melanoma that is unresectable or metastatic.
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Results 61 - 70 of 104
Results 61 - 70 of 104