Best Read Articles on FDA News in 2021
The FDA's warning about Xeljanz (tofacitinib) and other JAK inhiitors and the extension of its review of Janssen's CAR T therapy for multiple myeloma were among the best read articles about the agency in 2021.
FDA approves sNDAs for Vazalore
Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin.
FDA Rejects EUA for COVID-19 Respiratory Failure Therapy
The FDA didn’t have enough data to assess the risks and benefits of Zyesami.
FDA Extends Review of Janssen’s CAR T Therapy for Multiple Myeloma
The agency needs more time to review new information on the analytical method used.
FDA’s New Warning Includes Xeljanz, Other JAK Inhibitors
The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious cardiovascular events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.
FDA Pauses Clozapine REMS Program
New requirements resulted in long call wait times, which has led to patient access issues.
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PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
August 2nd 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
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FDA Extends Review of Blenrep Combinations in Multiple Myeloma
August 2nd 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
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